(229 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and clinical outcomes of guide wires and microcatheters, with no mention of AI or ML technologies.
Yes
The device is intended to facilitate the placement of balloon dilatation catheters and assist in crossing chronic total occlusions, which are therapeutic interventions.
No
Explanation: The device, ASAHI PTCA Guide Wires, is intended to facilitate the placement of balloon dilatation catheters, assist in crossing de novo CTOs, provide support for guide wires, and assist in the delivery of contrast media. Its primary function is interventional and therapeutic support, not diagnosis. While it aids in procedures that might involve imaging (like angiographic procedures), the device itself does not provide diagnostic information about a patient's condition.
No
The device description clearly details physical components like core wires, coils, coatings, and microcatheters, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in facilitating the placement of catheters and guide wires during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This is a surgical/interventional procedure, not an in vitro diagnostic test performed on samples outside the body.
- Device Description: The description details the physical components of guide wires and microcatheters, which are tools used directly within the patient's vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is an invasive medical device used in interventional cardiology and peripheral vascular procedures.
N/A
Intended Use / Indications for Use
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
ASAHI Corsair Microcatheter / ASAHI Corsair Pro Microcatheter:
This product is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary chronic total occlusions (CTO).
This device should not be used in neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
DOX, DOY
Device Description
The ASAHI® PTCA Guide Wires and ASAHI® Corsair® / ASAHI® Corsair® Pro Microcatheters covered by this submission are existing marketed devices. There have been no physical changes to the subject devices as compared to the currently marketed predicate devices except for a change in indication and related clinical information added to the labeling. The designs and performance of the guidewires are unchanged.
The ASAHI® PTCA Guide Wires consist of a core wire and a coil assembly. Depending on the model, the coil assembly could consist of an outer coil soldered to the core wire, or an inner coil and an outer coil, with or without a safety wire, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® PTCA Guide Wires. The coil and distal portion of the quidewire have a hydrophilic outer coating. The proximal portion of the guidewires are coated with PTFE. The ASAHI® PTCA Guide Wires are available in various lengths and tip shapes. The shorter length devices are designed for use with a commercially available Asahi Intecc extension wire.
The ASAHI Corsair / ASAHI Corsair Pro Microcatheter consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. No accessories are part of this device. The ASAHI Corsair has a radiopaque marker coil that is imbedded into the inner layer of resin to facilitate the tip location during angiographic procedures. In addition, the devices have a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the ASAHI Corsair / ASAHI Corsair Pro has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheters for the purposes of a smooth transition and exchange of guidewires.
The microcatheters also contain wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculatures, abdominal vasculatures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A prospective, multi-center, single-arm study of 163 subjects was performed to evaluate the safety and effectiveness of the ASAHI series of Guide Wires and/or Corsair Microcatheter (study devices) in patients with symptomatic ischemic heart disease attributed to a chronic total occlusion (CTO) in a native coronary artery. The primary objective of the trial was to evaluate placement of any guide wire beyond the CTO in the true vessel lumen in subjects in which at least one of the study devices were used. Procedure success was defined as (1) angiographic visualization of any guide wire crossing the target lesion and (2) absence of inhospital major adverse cardiac events (MACE), defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or postprocedural myocardial infarction (MI). For this study the definition of MI also included any CK-MB reading > 3xULN.
Key Results:
The procedure success rate for this study was 73.0% (p=0.0044). The Investigators successfully re-canalized the vessel in 89.0% of procedures. The absence of inhospital MACE was 81.0%. Study success was defined as meeting the primary endpoint of a successful re-canalization rate and absence of in-hospital MACE above 63.1% with a one-sided lower 95% confidence bound of 67.3%.
Key Results using SCAI recommended MI criteria:
Procedure Success: 84.7% (138/163) with a two-sided 95% CI of (79.1%, 90.2%) and a P-value of
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
February 12, 2018
Asahi Intecc Co., Ltd. % Candace Cederman Principal Consultant Cardiomed Device Consultants, LLC 3168 Braverton Street, Suite 200 Edgewater, Maryland 21037
Re: K171933
Trade/Device Name: ASAHI PTCA Guide Wires (ASAHI Gaia First, Gaia Second, Gaia Third; ASAHI Fielder XT: ASAHI Fielder XT-A, Fielder XT-R: ASAHI Miraclebros3, Miraclebros4.5. Miraclebros6. Miraclebros12: ASAHI Ultimate bros3. ASAHI Confianza; ASAHI Confianza Pro, Confianza Pro 12), ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter Regulation Number: 21 CFR 870.1330; 21 CFR 870.1250 Regulation Name: Catheter Guide Wire: Percutaneous Catheter Regulatory Class: Class II Product Code: DOX: DOY Dated: January 9, 2018 Received: January 11, 2018
Dear Candace Cederman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171933
Device Name
ASAHI® PTCA Guide Wire
•ASAHI Gaia First, Gaia Second, Gaia Third, •ASAHI Fielder XT, •ASAHI Fielder XT-A, •ASAHI Miraclebros3, Miraclebros4.5, Miraclebros12, •ASAHI Ultimate bros3, •ASAHI Confianza, •ASAHI Confianza Pro, Confianza Pro 12
Indications for Use (Describe)
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171933
Device Name
• ASAHI Corsair Microcatheter
· ASAHI Corsair Pro Microcatheter
Indications for Use (Describe)
This product is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary chronic total occlusions (CTO).
This device should not be used in neurovasculature.
| Type of Use (Select one or both, as applicable) |
|---|
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
ΛՏΛΗΙ INTECC CO.,LTD.
1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel. +81-52-768-1211 Fax. +81-52-768-1221 Branch offices: Tokyo, Nagoya, Osaka, Hong Kong, Amsterdam, Singapore, Beijing Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi
510(k) Summary [as required by 21 CFR 807.92(c)]
ASAHI® PTCA Guide Wire ASAHI® Corsair® / ASAHI® Corsair® Pro Microcatheter 510(k) __
| DATE PREPARED: | June 26, 2017 |
|---|---|
| APPLICANT | ASAHI INTECC CO., LTD. |
| 1703 Wakita-cho, Moriyama-ku | |
| Nagoya, Aichi 463-0024, Japan | |
| CONTACT | Yoshi Terai |
| President/CEO | |
| ASAHI INTECC USA, Inc. | |
| 2500 Red Hill Avenue, Suite 210 | |
| Santa Ana, CA 92705 | |
| Tel: (949) 756-8252, FAX: (949) 756-8165 | |
| e-mail: ASAHI.ra-fda@ASAHI-intecc.com | |
| TRADE NAME: | ASAHI® PTCA Guide Wire |
| • ASAHI Gaia First, Gaia Second, Gaia Third | |
| • ASAHI Fielder XT | |
| • ASAHI Fielder XT-A, Fielder XT-R | |
| • ASAHI MIRACLEbros 3, MIRACLEbros 4.5, MIRACLEbros 6, MIRACLEbros 12 | |
| • ASAHI ULTIMATEbros 3 | |
| • ASAHI Confianza | |
| • ASAHI Confianza Pro, Confianza Pro 12 | |
| ASAHI® Corsair® / ASAHI® Corsair® Pro Microcatheter | |
| • ASAHI Corsair | |
| • ASAHI Corsair Pro | |
| DEVICE | |
| CLASSIFICATION: | Class 2 per 21 CFR §870.1330 – Guide wires |
| Class 2 per 21 CFR §870.1250 - Catheter | |
| CLASSIFICATION | |
| NAME: | Catheter guide wire |
| Percutaneous catheter | |
| PRODUCT CODE | DQX - Wire, Guide, Catheter |
| DQY – Catheter, Percutaneous | |
| PREDICATE DEVICES: | ASAHI® PTCA Guide Wire |
| • ASAHI Gaia First, Gaia Second, Gaia Third (K133865) | |
| • ASAHI Fielder XT (K072431) | |
| • ASAHI Fielder XT-A, Fielder XT-R (K153106) | |
| • ASAHI MIRACLEbros 3, MIRACLEbros 4.5, MIRACLEbros 6 (K022762, K031277) | |
| • ASAHI MIRACLEbros 12 (K052339) | |
| • ASAHI ULTIMATEbros 3 (K101986) | |
| • ASAHI Confianza (K022762, K031277) | |
| • ASAHI Confianza Pro (K041531) |
5
| ASAHI® Corsair® / ASAHI Corsair® Pro Microcatheter |
|---|
| ASAHI Corsair (K083127, K151103) |
| ASAHI Corsair Pro (K161126) |
Intended Use/Indications for Use
ASAHI PTCA Guide Wires:
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
ASAHI Corsair Microcatheter / ASAHI Corsair Pro Microcatheter:
This product is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary chronic total occlusions (CTO).
This device should not be used in neurovasculature.
Device Description:
The ASAHI® PTCA Guide Wires and ASAHI® Corsair® / ASAHI® Corsair® Pro Microcatheters covered by this submission are existing marketed devices. There have been no physical changes to the subject devices as compared to the currently marketed predicate devices except for a change in indication and related clinical information added to the labeling. The designs and performance of the guidewires are unchanged.
The ASAHI® PTCA Guide Wires consist of a core wire and a coil assembly. Depending on the model, the coil assembly could consist of an outer coil soldered to the core wire, or an inner coil and an outer coil, with or without a safety wire, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® PTCA Guide Wires. The coil and distal portion of the quidewire have a hydrophilic outer coating. The proximal portion of the guidewires are coated with PTFE. The ASAHI® PTCA Guide Wires are available in various lengths and tip shapes. The shorter length devices are designed for use with a commercially available Asahi Intecc extension wire.
The ASAHI Corsair / ASAHI Corsair Pro Microcatheter consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. No accessories are part of this device. The ASAHI Corsair has a radiopaque marker coil that is imbedded into the inner layer of resin to facilitate the tip location during angiographic procedures. In addition, the devices have a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the ASAHI Corsair / ASAHI
6
Corsair Pro has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheters for the purposes of a smooth transition and exchange of guidewires.
The microcatheters also contain wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.
Comparison with Predicate device:
The devices included in this submission are unchanged from the predicate devices. The technological characteristics of the Subject devices such as the components, design, materials, sterilization method, shelf life and operating principle are identical to the currently marketed predicate devices. This submission covers only the inclusion of additional language in the Indications for Use.
| Name of Device | ASAHI PTCA Guide wire | ASAHI PTCA Guide wire
(Predicate) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Current Application | K022762, K031277, K041531,
K052339, K072431, K101986,
K133865, K153106 |
| Intended Use and
Indications | ASAHI PTCA Guide Wires are
intended to facilitate the
placement of balloon dilatation
catheters during percutaneous
transluminal coronary
angioplasty (PTCA) and
percutaneous transluminal
angioplasty (PTA), including
use in crossing or assisting in
crossing de novo coronary
chronic total occlusions (CTO).
The ASAHI PTCA Guide Wires
are not to be used in the
neurovasculature. | ASAHI PTCA Guide Wires are
intended to facilitate the
placement of balloon dilatation
catheters during percutaneous
transluminal coronary
angioplasty (PTCA) and
percutaneous transluminal
angioplasty (PTA). The ASAHI
PTCA Guide Wires are not to
be used in the
neurovasculature. |
| Sterilization | Identical | Identical |
| Shelf Life | Identical | Identical |
| Target Body Location | Identical | |
| Outer Coil Material | Identical | |
| Core Wire Material | Identical | |
| Inner Coil Material | Identical | |
| Distal Tip Shape | Identical | |
| Overall length | Identical | |
| Outer coil length | Identical | |
| Outer Coil Outer
Diameter | Identical | |
| Distal Outer Coating | Identical | |
| Proximal Coating | Identical | |
7
| Name of Device | ASAHI Corsair Microcatheter
ASAHI Corsair Pro
Microcatheter | ASAHI Corsair Microcatheter
ASAHI Corsair Pro Microcatheter |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Current Application | K083127, K151103, K161126 |
| Intended Use and
Indications | This product is intended to
provide support to facilitate the
placement of guide wires in the
coronary and peripheral
vasculatures, and can be used to
exchange one guide wire for
another.
This product is also intended to
assist in the delivery of contrast
media into the coronary,
peripheral and abdominal
vasculatures, and to assist in
crossing de novo coronary
chronic total occlusions (CTO).
This device should not be used in
neurovasculature. | The ASAHI Corsair is intended to
provide support to facilitate the
placement of guide wires in the
coronary and peripheral vasculature,
and can be used to exchange one
guide wire for another. The ASAHI
Corsair is also intended to assist in
the delivery of contrast media in the
coronary, peripheral, and abdominal
vasculature.
The ASAHI Corsair Pro is intended to
provide support to facilitate the
placement of guide wires in the
coronary and peripheral vasculature,
and can be used to exchange one
guide wire for another. The ASAHI
Corsair Pro is also intended to assist
in the delivery of contrast media in the
coronary, peripheral, and abdominal
vasculature.
This device should not be used in
neurovasculature. |
| Sterilization | Identical | |
| Shelf Life | Identical | |
| Target Body Location | Identical | |
| Overall length | Identical | |
| Nominal Outer Diameter | Identical | |
| Coating Length | Identical | |
| Distal Tip Outer Diameter | Identical | |
| Distal Tip Inner Diameter | Identical | |
| Shaft Tube Outer
Diameter | Identical | |
| Shaft Tube Inner Diameter | Identical | |
| Materials | Identical | |
Non Clinical testing - Performance Data / Biocompatibility / Packaging and STERILIZATION TESTING:
There have been no physical changes to the subject devices as compared to the predicate devices. Comparisons of bench, biocompatibility, packaging, and sterilization testing are not necessary. The subject and predicate devices are identical and bench testing, biocompatibility, packaging, and sterilization for the subject devices are therefore substantially equivalent to their respective predicate devices.
CLINICAL TESTING:
A prospective, multi-center, single-arm study of 163 subjects was performed to evaluate the safety and effectiveness of the ASAHI series of Guide Wires and/or Corsair Microcatheter (study devices) in patients with symptomatic ischemic heart disease attributed to a chronic total occlusion (CTO) in a native coronary artery. The primary objective of the trial was to evaluate placement of any guide wire beyond the CTO in the true vessel lumen in subjects in which at least one of the
8
study devices were used. Procedure success was defined as (1) angiographic visualization of any guide wire crossing the target lesion and (2) absence of inhospital major adverse cardiac events (MACE), defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or postprocedural myocardial infarction (MI). For this study the definition of MI also included any CK-MB reading > 3xULN.
Primary Endpoint Results and Analysis
The procedure success rate for this study was 73.0% (p=0.0044). The Investigators successfully re-canalized the vessel in 89.0% of procedures. The absence of inhospital MACE was 81.0%. Study success was defined as meeting the primary endpoint of a successful re-canalization rate and absence of in-hospital MACE above 63.1% with a one-sided lower 95% confidence bound of 67.3%. A summary of primary endpoint procedure success is provided in the table below.
| Parameter | Result | Two-Sided 95% CI | Performance Goal | Lower Bound of One-Sided 95% CI | P-value |
|---|---|---|---|---|---|
| Procedure Success | 73.0% (119/163) | (66.2%, 79.8%) | 63.1% | 67.3% | 0.0044 |
| Successful re-canalization | 89.0% (145/163) | --- | --- | --- | --- |
| Absence of in-hospital MACE | 81.0% (132/163) | --- | --- | --- | --- |
Repeating this same data, using the criteria for a clinically relevant MI as recommended in the Expert Consensus Document from the Society for Cardiovascular Angiography and Interventions (SCAI) published in 2013.
| Parameter | Result | Two-Sided
95% Cl | Performance
Goal | Lower
Bound of
One-Sided
95% Cl | P-value |
|-----------------------------------|--------------------|---------------------|---------------------|------------------------------------------|---------|
| Procedure
Success | 84.7%
(138/163) | (79.1%,
90.2%) | 63.1% | 80.0% |