(237 days)
No
The device description and performance studies focus on mechanical components and clinical outcomes, with no mention of AI or ML.
Yes
The device is used in conjunction with PCI, traps and extracts thrombotic and atheromatous debris, and protects against distal embolization, indicating a therapeutic rather than diagnostic purpose.
No
Explanation: The device description and intended use clearly state that the TriActiv® System is an "embolic protection device" used to trap and extract debris during PCI. It does not mention any diagnostic capabilities, such as identifying or characterizing a disease.
No
The device description explicitly lists multiple hardware components including a guidewire, syringe, catheter, and flow control unit.
Based on the provided information, the TriActiv® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used in conjunction with percutaneous coronary intervention (PCI) to trap and extract debris during the procedure. This is an interventional device used directly on the patient's vasculature.
- Device Description: The description details a system of physical components (guidewire, syringe, catheter, flow control) used to perform a mechanical action within the body.
- Mechanism of Action: The device works by physically occluding the vessel and extracting debris. This is a mechanical process, not a diagnostic test performed on a sample outside the body.
- Anatomical Site: The device is used within the saphenous vein coronary bypass grafts, which is an in-vivo application.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the device during the procedure, not to analyze a sample.
IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The TriActiv® System does not perform this function. It is a therapeutic and protective device used during a medical procedure.
N/A
Intended Use / Indications for Use
The TriActiv® System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0mm to 5.0mm in diameter. The TriActiv® System is intended to protect the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.
Product codes (comma separated list FDA assigned to the subject device)
NFA
Device Description
The TriActiv® System is a temporary balloon occlusion embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts ranging from 3.0mm to 5.0mm in diameter. The device is comprised of four principal components: ShieldWire™ Temporary Occlusion Balloon Guidewire ("balloon guidewire"), Balloon Inflation Syringe, FlushCath™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also five subcomponents or accessories included in the TriActiv® System: the split tube introducer, guidewire plug and installer, AutoStream™ Flow Control Power Supply, TriActiv® Tuohy, and flush catheter attachment tool. All TriActiv® System components are supplied sterile and for single use only with exception of the AutoStream™ Flow Control Power Supply which is non-sterile and reusable. The balloon guidewire is advanced through the hospital supplied 7F guide catheter (without sideholes) prior to percutaneous coronary intervention of a saphenous vein graft (SVG) and positioned just past the target lesion.
The balloon is inflated with carbon dioxide (CO2) gas, creating a protected space between the guide catheter and the balloon. Once the balloon is inflated and vessel occlusion is confirmed, PTCA and/or stenting can be performed over the balloon guidewire. Immediately after intervention, the flush catheter is attached to the balloon guidewire and advanced into the graft. With the flush catheter positioned just proximal to the balloon, the flow control delivers saline through the flush catheter to gently wash the vessel and remove any debris generated during the intervention through the guide catheter into a collection bag. The TriActiv® System has been designed to extract at a greater rate than it infuses to prevent aortic embolization. Once the physician is satisfied with the amount of debris removed from the vessel, the protection balloon is deflated and the device is removed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
saphenous vein coronary bypass grafts, distal coronary vasculature
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)
Non-clinical verification and validation of the TriActiv® System has been performed through extensive in vitro bench testing, biocompatibility testing, software validation, package integrity testing, shelf life testing, and in vivo animal studies. Results of this testing indicate that the TriActiv® System design meets all specifications and intended use.
Clinical evaluation of the TriActiv® System was conducted in a non-randomized European CE Mark study, a U.S. pilot study, and the randomized PRIDE (PRotection during Saphenous Vein Graft Intervention to Prevent Distal Embolization) Study. Enrollment in PRIDE began on 12/4/01 and ended on 3/26/04. There were 68 sites in the United States and 10 sites in Europe who participated in PRIDE. The PRIDE Study involved a total of 894 vein graft patients (including roll-in, Cohort 1 and Cohort 2 patients). Due to the quick adoption of embolic protection as the standard of care for SVG intervention early on in the PRIDE Trial, there was a very low rate of enrollment in Cohort 1. Cohort 1 evaluated 33 patients treated with the TriActiv® System vs. 29 patients treated with no embolic protection. The total number of patients in Cohort 1 was too small to statistically analyze and therefore no analysis was performed. PRIDE Study Cohort 2 consisted of 631 patients total; 313 randomized to the TriActiv® arm and 318 randomized to the Active Control arm (either FilterWire® EX Embolic Protection System or GuardWire® Plus Temporary Occlusion and Aspiration System).
Table 1: Distribution of Patients According to Randomized Treatment and Treatment Actually Received
All Groups: Number of Patients As Assigned Randomized: 894, Number of Patients As Received: 893
Roll-In: Number of Patients As Assigned Randomized: 201, Number of Patients As Received: 200
TriActiv® Cohort 1: Number of Patients As Assigned Randomized: 33, Number of Patients As Received: 33
Placebo Cohort 1: Number of Patients As Assigned Randomized: 29, Number of Patients As Received: 31
TriActiv® Cohort 2: Number of Patients As Assigned Randomized: 313, Number of Patients As Received: 310
Active Control Cohort 2: Number of Patients As Assigned Randomized: 318, Number of Patients As Received: 319
The 30-day MACE (Major Adverse Cardiovascular Events) rates in Cohort 1 are as follows: 18.3% (6/33) for TriActiv® and 10.2% (3/29) for placebo. Due to small number of patients in Cohort 1, statistical analysis to assess superiority is not appropriate, and therefore was not performed.
The 30-day MACE rates in Cohort 2 are as follows: 11.2% (35/313) for TriActiv® and 10.1% (32/318) for Active Control. The non-inferiority hypothesis was based on the Cohort 2 data and required that the MACE rate through 30-days for the TriActiv® group versus the Active Control group not be statistically different when tested to a delta of 6%. The PRIDE Study met its non-inferiority hypothesis with a p-value of 0.023 relative to the delta of 6.0%. The upper one-sided 95% confidence bound on the difference in 30-day MACE rates was 0.0515; hence, the PRIDE Study would have achieved noninferiority to the active control with a delta as small as 5.2%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Table 2: Principal Results (Intent to Treat Analysis)
MACE to 30 days:
TriActiv® (N=33): 6 (18.2%)
Placebo (N=29): 3 (10.3%)
TriActiv® (N=313): 35 (11.2%)
Active Control (N=318): 32 (10.1%)
Difference (95% CB): 1.1% (5.2%)
Death:
TriActiv® (N=33): 0 (0%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 4 (1.3%)
Active Control (N=318): 2 (0.6%)
Difference (95% CB): 0.7% (1.9%)
Cardiac Death:
TriActiv® (N=33): 0 (0%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 4 (1.3%)
Active Control (N=318): 2 (0.6%)
Difference (95% CB): 0.7% (1.9%)
Non Cardiac Death:
TriActiv® (N=33): 0 (0%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 0 (0%)
Active Control (N=318): 0 (0%)
Difference (95% CB): 0% (-)
MI:
TriActiv® (N=33): 5 (15.2%)
Placebo (N=29): 3 (10.3%)
TriActiv® (N=313): 31 (9.9%)
Active Control (N=318): 28 (8.8%)
Difference (95% CB): 1.1% (4.9%)
Q wave MI:
TriActiv® (N=33): 0 (0%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 4 (1.3%)
Active Control (N=318): 1 (0.3%)
Difference (95% CB): 1.0% (2.1%)
Non-Q wave MI:
TriActiv® (N=33): 5 (15.2%)
Placebo (N=29): 3 (10.3%)
TriActiv® (N=313): 27 (8.6%)
Active Control (N=318): 27 (8.5%)
Difference (95% CB): 0.1% (3.8)
Emergent CABG:
TriActiv® (N=33): 0 (0%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 0 (0%)
Active Control (N=318): 0 (0%)
Difference (95% CB): 0% (-)
TVR:
TriActiv® (N=33): 2 (6.1%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 5 (1.6%)
Active Control (N=318): 4 (1.3%)
Difference (95% CB): 0.3% (1.9%)
MACE-in-hospital:
TriActiv® (N=33): 5 (15.2%)
Placebo (N=29): 3 (10.3%)
TriActiv® (N=313): 31 (9.9%)
Active Control (N=318): 29 (9.1%)
Difference (95% CB): 0.8 (4.6%)
Stroke-in-hospital:
TriActiv® (N=33): 0 (0%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 1 (0.3%)
Active Control (N=318): 1 (0.3%)
Difference (95% CB): 0% (0.7%)
Stroke-discharge to end of study:
TriActiv® (N=33): 0 (0%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 0 (0%)
Active Control (N=318): 0 (0%)
Difference (95% CB): 0% (-)
Hemorrhagic/vascular complications-in-hosp:
TriActiv® (N=33): 1 (3.0%)
Placebo (N=29): 2 (6.9%)
TriActiv® (N=313): 34 (10.9%)
Active Control (N=318): 17 (5.4%)
Difference (95% CB): 5.5% (9.1%)
7 F:
TriActiv® (N=33): 1 (7.1%)
Placebo (N=29): 1 (16.7%)
TriActiv® (N=313): 9 (6.3%)
Active Control (N=318): 8 (5.5%)
Difference (95% CB): 0.8% (5.4%)
8 F:
TriActiv® (N=33): 0 (0%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 23 (15.4%)
Active Control (N=318): 5 (3.9%)
Difference (95% CB): 11.5% (17.2%)
Transfusion:
TriActiv® (N=33): 1 (3.0%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 24 (7.7%)
Active Control (N=318): 11 (3.5%)
Difference (95% CB): 4.2% (7.2%)
7 F:
TriActiv® (N=33): 1 (7.1%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 5 (3.5%)
Active Control (N=318): 5 (3.5%)
Difference (95% CB): 0.1% (3.6%)
8 F:
TriActiv® (N=33): 0 (0.0%)
Placebo (N=29): 0 (0%)
TriActiv® (N=313): 17 (11.4%)
Active Control (N=318): 3 (2.3%)
Difference (95% CB): 9.1% (13.9%)
Device Success:
TriActiv® (N=33): 31 (93.9%)
TriActiv® (N=313): 293 (94.5%)
Procedure Success/Patient:
TriActiv® (N=33): 27/32 (84.4%)
Placebo (N=29): 25/29 (86.2%)
TriActiv® (N=313): 278/311 (89.4%)
Active Control (N=318): 286/316 (90.5%)
Difference (95% CB): 1.1% (5.1%)
Lesion Success/Lesion:
TriActiv® (N=33): 32/32 (100%)
Placebo (N=29): 27/29 (93.1%)
TriActiv® (N=313): 308/311 (99.0%)
Active Control (N=318): 313/315 (99.4%)
Difference (95% CB): 0.3% (1.5%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Koy2040
510(k) Summary
| Submitter Information: | Kensey Nash Corporation
55 E. Uwchlan Avenue
Exton, PA 19341 USA
Robin M. Fatzinger, RAC
V.P. of Clinical & Regulatory Affairs
Fax: 610-524-0265
Tel: 610-524-0188 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | TriActiv® System |
| Common Name: | Distal Occlusion Balloon Catheter |
| Classification Name: | Device, Coronary Saphenous Vein Bypass Graft,
Temporary For Embolization Protection (per 21 CFR
section 870.1250) |
| Regulatory Class: | Class II |
| Device Product Code: | NFA |
| 510(k) Number: | K042040 |
| Predicate Device: | K013913 - PercuSurge GuardWire® Temporary Occlusion
and Aspiration System |
| Date Prepared: | February 14, 2005 |
Description of Device
The TriActiv® System is a temporary balloon occlusion embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts ranging from 3.0mm to 5.0mm in diameter. The device is comprised of four principal ShieldWire™ Temporary Occlusion Balloon Guidewire ("balloon components: guidewire), Balloon Inflation Syringe, FlushCath™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also five subcomponents or accessories included in the TriActiv® System: the split tube introducer, guidewire plug and installer, AutoStream™ Flow Control Power Supply, TriActiv® Tuohy, and flush catheter attachment tool. All TriActiv® System components are supplied sterile and for single use only with exception of the AutoStream™ Flow Control Power Supply which is non-sterile and reusable. The balloon guidewire is advanced through the hospital supplied 7F guide catheter (without sideholes) prior to percutaneous coronary intervention of a saphenous vein graft (SVG) and positioned just past the target lesion.
1
The balloon is inflated with carbon dioxide (CO2) gas, creating a protected space between the guide catheter and the balloon. Once the balloon is inflated and vessel occlusion is confirmed, PTCA and/or stenting can be performed over the balloon guidewire. Immediately after intervention, the flush catheter is attached to the balloon guidewire and advanced into the graft. With the flush catheter positioned just proximal to the balloon, the flow control delivers saline through the flush catheter to gently wash the vessel and remove any debris generated during the intervention through the guide catheter into a collection bag. The TriActiv® System has been designed to extract at a greater rate than it infuses to prevent aortic embolization. Once the physician is satisfied with the amount of debris removed from the vessel, the protection balloon is deflated and the device is removed.
1. ShieldWire™ Temporary Occlusion Balloon Guidewire
The ShieldWire™ Temporary Occlusion Balloon Guidewire is a single-use 0.014-inch hypo-tube guidewire with a shapeable radiopaque floppy tip and an integrated proprietary latex distal protection balloon used to occlude a 3.0mm to 5.0mm vessel. It is available in 190cm and 340cm lengths. The latex balloon is mounted over two inflation holes, which allow the balloon to be inflated with CO2 through the central lumen of the hypotube lumen. The use of CO2 as an inflation medium, allows for rapid inflation and deflation of the protection balloon. The balloon is inflated using the Balloon Inflation Syringe. Under fluoroscopic visualization, the physician may adjust the balloon size with the inflation syringe in order to fully occlude vessels between 3.0mm and 5.0mm. The guidewire is coated to reduce surface friction and allow for easier delivery of interventional devices. A radiopaque tip stop is soldered to the distal segment just proximal to the balloon to protect the balloon from damage due to a PTCA or stent catheter and to provide visualization under fluoroscopy. The split tube introducer is an accessory used to protect the balloon and floppy tip during introduction through the TriActiv® Tuohy valve. The proximal end of the guidewire is sealed with a removable guidewire plug to prevent debris or fluid from entering the lumen during catheter exchanges. Just prior to balloon inflation, the guidewire plug is removed from the proximal end of the guidewire. An additional guidewire plug is provided with the system within the guidewire plug installer, which protects the plug and aids with insertion of the plug into the guidewire.
2. Balloon Inflation Syringe
The Balloon Inflation Syringe is used to inflate the guidewire occlusion balloon with CO2. It is mainly comprised of a 3.0cc syringe with a pediatric Tuohy-Borst valve, which locks the syringe onto the guidewire. A volume control knob allows for incremental increases in CO2. The syringe is pre-filled with enough USP grade CO2 to occlude a 3.0mm to 5.0mm diameter vessel. To inflate the balloon, the plunger is depressed and released. A volume control knob may be twisted in a clockwise direction to increase the balloon diameter to occlude blood flow in larger vessels up to 5.0mm.
2
3. AutoStream™ Flow Control
The AutoStream™ Flow Control is a single use AC powered fluid flow control system with integrated tubing. The flow control incorporates mechanical pumps for fluid infusion and debris extraction as well as the tubing used to connect the flow control to the FlushCath™ Catheter (infusion) and the TriActiv® Tuohy (extraction). The sterile flow control is powered by a reusable non-sterile power supply that is kept out of the sterile field. The flow control user interface incorporates 3 buttons and a digital numeric readout. A simple electronic circuit with a pre-programmed microprocessor controls all the functions of the unit. The flush catheter delivers infusate while extraction occurs simultaneously. The AutoStream™ Flow Control Power Supply is a non-sterile, reusable power cord used to provide power from an electrical outlet to the flow control. The TriActiv® Tuohy is a multiple port Tuohy-Borst valve that is attached to the guide catheter by a rotating luer and allows interventional access. It also provides an angiographic interface and port for extraction of debris.
4. FlushCath™ Catheter
The FlushCath™ Catheter is a side attachable, 3F catheter with a radiopaque marker to aid in placement. The flush catheter is used to wash debris from the target vessel, which is then extracted into the collection bag. Attachment is achieved by pressing the guidewire into a 2 cm slit in the side of the catheter tip thereby placing the guidewire into the lumen of the catheter, creating a short mono-rail. The flush catheter attachment tool facilitates this process.
Intended Use of Device
The TriActiv® System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0mm to 5.0mm in diameter. The TriActiv® System is intended to protect the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.
Technological Characteristics
The technological characteristics of the TriActiv® System are substantially equivalent to the predicate device in that they are both coronary embolic protection devices which trap and extract debris loosened during percutaneous coronary intervention of diseased saphenous vein bypass grafts. In addition, both systems utilize a 0.014-inch diameter temporary occlusion balloon guidewire. The primary technological differences include the CO2 inflated distal occlusion balloon to improve speed of inflation and deflation. automated extraction to eliminate manual "syringing" of debris, and automated flushing during extraction to assist in debris removal.
3
Non-Clinical and Clinical Summary
Non-clinical verification and validation of the TriActiv® System has been performed through extensive in vitro bench testing, biocompatibility testing, software validation, package integrity testing, shelf life testing, and in vivo animal studies. Results of this testing indicate that the TriActiv® System design meets all specifications and intended use.
Clinical evaluation of the TriActiv® System was conducted in a non-randomized European CE Mark study, a U.S. pilot study, and the randomized PRIDE (PRotection during Saphenous Vein Graft Intervention to Prevent Distal Embolization) Study. Enrollment in PRIDE began on 12/4/01 and ended on 3/26/04 (duration of enrollment was 2 years, 3 months, and 22 days). The last patient visit occurred in late April 2004 and the database was locked on 7/2/04. There were 68 sites in the United States and 10 sites in Europe who participated in PRIDE. Refer to Table 1 for a breakdown of patients according to treatment group. The PRIDE Study involved a total of 894 vein graft patients (including roll-in, Cohort 1 and Cohort 2 patients). Due to the quick adoption of embolic protection as the standard of care for SVG intervention early on in the PRIDE Trial, there was a very low rate of enrollment in Cohort 1. Cohort 1 evaluated 33 patients treated with the TriActiv® System vs. 29 patients treated with no embolic protection. The total number of patients in Cohort 1 was too small to statistically analyze and therefore no analysis was performed. PRIDE Study Cohort 2 consisted of 631 patients total; 313 randomized to the TriActiv® arm and 318 randomized to the Active Control arm (either FilterWire® EX Embolic Protection System or GuardWire® Plus Temporary Occlusion and Aspiration System).
| Treatment Group | Number of Patients
As Assigned Randomized | Number of Patients
As Received |
|-------------------------|----------------------------------------------|-----------------------------------|
| All Groups | 894 | 893 |
| Roll-In | 201 | 200 |
| TriActiv® Cohort 1 | 33 | 33 |
| Placebo Cohort 1 | 29 | 31 |
| TriActiv® Cohort 2 | 313 | 310 |
| Active Control Cohort 2 | 318 | 319 |
Table 1: Distribution of Patients According to Randomized Treatment and Treatment Actually Received
The 30-day MACE rates in Cohort 1 are as follows: 18.3% (6/33) for TriActiv® and 10.2% (3/29) for placebo. Due to small number of patients in Cohort 1, statistical analysis to assess superiority is not appropriate, and therefore was not performed.
The 30-day MACE rates in Cohort 2 are as follows: 11.2% (35/313) for TriActiv® and 10.1% (32/318) for Active Control. The non-inferiority hypothesis was based on the Cohort 2 data and required that the MACE rate through 30-days for the TriActiv® group versus the Active Control group not be statistically different when tested to a delta of 6%. The PRIDE Study met its non-inferiority hypothesis with a p-value of 0.023 relative to the delta of 6.0%. The upper one-sided 95% confidence bound on the difference in 30
4
day MACE rates was 0.0515; hence, the PRIDE Study would have achieved noninferiority to the active control with a delta as small as 5.2%.
| | Roll-in | TriActiv®
(N=33)
n (%) | Placebo
(N=29)
n (%) | TriActiv®
(N=313)
n (%) | Active
Control
(N=318)
n (%) | Difference
(95% CB) |
|---------------------------------------------------|--------------------|------------------------------|----------------------------|-------------------------------|---------------------------------------|------------------------|
| MACE to 30 days | 29 (14.4%) | 6 (18.2%) | 3 (10.3%) | 35 (11.2%) | 32 (10.1%) | 1.1%
(5.2%) |
| Death | 2 (1.0%) | 0 (0%) | 0 (0%) | 4 (1.3%) | 2 (0.6%) | 0.7%
(1.9%) |
| Cardiac | 1 (0.5%) | 0 (0%) | 0 (0%) | 4 (1.3%) | 2 (0.6%) | 0.7%
(1.9%) |
| Non Cardiac2 | 1 (0.5%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0% (-) |
| MI | 26 (12.9%) | 5 (15.2%) | 3 (10.3%) | 31 (9.9%) | 28 (8.8%) | 1.1%
(4.9%) |
| Q wave | 4 (2.0%) | 0 (0%) | 0 (0%) | 4 (1.3%) | 1 (0.3%) | 1.0%
(2.1%) |
| Non-Q wave | 22 (11.0%) | 5 (15.2%) | 3 (10.3%) | 27 (8.6%) | 27 (8.5%) | 0.1% (3.8) |
| Emergent CABG | 1 (0.5%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0% (-) |
| TVR | 4 (2.0%) | 2 (6.1%) | 0 (0%) | 5 (1.6%) | 4 (1.3%) | 0.3%
(1.9%) |
| MACE-in-hospital | 25 (12.4%) | 5 (15.2%) | 3 (10.3%) | 31 (9.9%) | 29 (9.1%) | 0.8 (4.6%) |
| Stroke-in-hospital | 1 (0.5%) | 0 (0%) | 0 (0%) | 1 (0.3%) | 1 (0.3%) | 0% (0.7%) |
| Stroke-discharge to
end of study | 1 (0.5%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0% (-) |
| Hemorrhagic/vascular
complications-in-
hosp | 23 (11.4%) | 1 (3.0%) | 2 (6.9%) | 34 (10.9%) | 17 (5.4%) | 5.5%
(9.1%) |
| 7 F | 2 (6.9%) | 1 (7.1%) | 1 (16.7%) | 9 (6.3%) | 8 (5.5%) | 0.8%
(5.4%) |
| 8 F | 19 (12.0%) | 0 (0%) | 0 (0%) | 23 (15.4%) | 5 (3.9%) | 11.5%
(17.2%) |
| Transfusion | 16 (8.0%) | 1 (3.0%) | 0 (0%) | 24 (7.7%) | 11 (3.5%) | 4.2%
(7.2%) |
| 7 F | 2 (6.9%) | 1 (7.1%) | 0 (0%) | 5 (3.5%) | 5 (3.5%) | 0.1%
(3.6%) |
| 8 F | 13 (8.2%) | 0 (0.0%) | 0 (0%) | 17 (11.4%) | 3 (2.3%) | 9.1%
(13.9%) |
| Device Success | 181
(90.0%) | 31 (93.9%) | N/A | 293
(94.5%) | - | - |
| Procedure
Success/Patient3 | 173/200
(86.5%) | 27/32
(84.4%) | 25/29
(86.2%) | 278/311
(89.4%) | 286/316
(90.5%) | 1.1%
(5.1%) |
| Lesion
Success/Lesion4 | 197/200
(98.5%) | 32/32
(100%) | 27/29
(93.1%) | 308/311
(99.0%) | 313/315
(99.4%) | 0.3%
(1.5%) |
Table 2: Principal Results (Intent to Treat Analysis)
1 Difference in percentages between TriActive Cohort 2 and the active control (one-sided 95% upper confidence bound on the difference)
2 Non-cardiac death is not a MACE as defined in the protocol, but is shown for comparison to cardiac death, which is a MACE as defined in the protocol
3 Final stenosis