(100 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical function and clinical outcomes of a balloon catheter, with no mention of AI/ML or related technologies.
Yes
The device is a coronary dilatation catheter used for balloon dilatation of stenotic portions of coronary arteries or bypass grafts, coronary artery occlusions, and previously implanted stents to improve myocardial perfusion and restore coronary flow. These actions directly treat a medical condition.
No.
This device is a therapeutic device used for coronary artery dilatation. Its function is to treat stenotic or occluded coronary arteries, not to diagnose them.
No
The device description clearly details physical components such as a balloon, shaft, radiopaque markers, and a hub, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The device description and intended use clearly indicate that the MINI TREK catheters are used within the human body for mechanical dilatation of coronary arteries and bypass grafts. They are interventional devices, not diagnostic tools that analyze biological samples.
- The device's function is mechanical intervention. The core function is to inflate a balloon to physically open a narrowed or blocked blood vessel. This is a therapeutic action, not a diagnostic test.
- The performance data relates to clinical outcomes of the intervention. The metrics reported (successful pre-dilatation, successful delivery, absence of complications, TIMI flow, device success, procedure success, MACE events) are all measures of the effectiveness and safety of the procedure performed with the device, not the results of a diagnostic test on a sample.
Therefore, the MINI TREK RX, MINI TREK OTW, and MINI TREK II OTW Coronary Dilatation Catheters are medical devices used for interventional procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MINI TREK RX, MINI TRETK OTW and MINI TREK II OTW Coronary Dilatation Catheters (balloon models 1.50 mm - 2.00 mm) are indicated for:
· Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion
· Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction
· Balloon dilatation of a stent after implantation (balloon models 2.00 mm only)
· Balloon dilatation of de novo chronic total coronary occlusions (CTO)
The MINI TREK RX, MINI TREK OTW and MINI TREK II OTW Coronary Dilatation Catheters (balloon models 1.20 mm) are indicated for:
· Initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (>= 70% stenosis)
· Balloon dilatation of de novo chronic total coronary occlusions (CTO)
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
The MINI TREK RX Coronary Dilatation Catheter is a rapid exchange co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section ending distal to the guide wire notch junction, along with brachial and femoral markers.
The MINI TREK OTW Coronary Dilatation Catheter is an over-the-wire (OTW) co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.
The MINI TREK II OTW Coronary Dilatation Catheter is an over-the-wire (OTW) co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery, bypass graft
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)
The primary objective of the EXPERT CTO clinical trial is to assess the safety and effectiveness of the MINI TREK Coronary Dilatation Catheter in predilatation of chronic total occlusions.
Total analysis population of 88 subjects (N=88) includes 65 subjects with evaluable data for the MINI TREK related primary analysis, and 23 subjects that did not have core laboratory ascertained angiography data immediately following pre-dilatation with the MINI TREK Coronary Dilatation Catheter.
The angioplasty pre-dilatation related primary endpoint was successful pre-dilatation of the CTO defined as: (1) successful delivery of the MINI TREK Coronary Dilatation Catheter to and across the target lesion and; (2) successful inflation and deflation of the MINI TREK Coronary Dilatation Catheter and; (3) absence (as determined by independent angiographic core laboratory assessment) of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline and clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI TREK and; (4) achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure (i.e. after stent implantation).
The mean (±SD) age of the subjects was 61.52 (±10.37) years. 76.1% (67/88) were men and 23.9% (21/88) were women.
The primary endpoint, successful pre-dilatation of the CTO, was achieved in 93.2% (82/88) of the 88 subjects in the total analysis population with a 95% confidence interval (CI) of [85.7%, 97.5%].
Successful delivery of at least one MINI TREK balloon to and across the target lesion occurred in 96.6% (85/88).
Successful inflation and deflation with at least one MINI TREK balloon occurred in 100.0% (85/85).
Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in TIMI from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following the dilatation with the MINI TREK balloon occurred in 97.7% (86/88).
Final TIMI 3 flow at the conclusion of the index procedure (i.e. after stent implantation) occurred in 98.9% (87/88).
Device success, defined as attainment of
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.
0
SECTION 2 – 510(k) SUMMARY – K123279
The 510(k) Summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.
| 1. SUBMITTER'S NAME | Abbott Vascular |
|---|---|
| 2. SUBMITTER'S ADDRESS | • PO Box 9018, Temecula, CA 92590-9018 |
| • 26531 Ynez Road, Temecula, CA 92591 | |
| 3. TELEPHONE | (951) 914-3243 |
| 4. FAX | (951) 914-0339 |
| 5. CONTACT PERSON | Suzanne Redman |
| 6. DATE PREPARED | October 19, 2012 |
| 7. DEVICE TRADE NAME | • MINI TREK™ RX Coronary Dilatation Catheter |
| • MINI TREK™ OTW Coronary Dilatation Catheter | |
| • MINI TREK™ II OTW Coronary Dilatation Catheter | |
| 8. DEVICE COMMON NAME | • Coronary Dilatation Catheter |
| • Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | |
| 9. DEVICE CLASSIFICATION NAME | PTCA Catheter, LOX, Class II, 21 CFR 870.5100 |
| 10. PREDICATE DEVICE NAME | • MINI TREK™ RX Coronary Dilatation Catheter |
| • MINI TREK™ OTW Coronary Dilatation |
- Catheter
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JAN 3 0 2013
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K123279 Page 2 of 9.
DEVICE DESCRIPTION 11.
MINI TREK RX Coronary Dilatation Catheter 11.1
The MINI TREK RX Coronary Dilatation Catheter is a rapid exchange co-axial design with a balloon at the distal tip. Table 2-1 provides a matrix of the balloon diameters and lengths available for the MINI TREK RX family of devices.
| Balloon
| Diameter | Balloon Length | ||||||
|---|---|---|---|---|---|---|---|
| (mm) | 6mm | 8mm | 12mm | 15mm | 20mm | 25mm | 30mm |
| 1.20 | X | X | X | X | X | ||
| 1.50 | X | X | X | X | X | ||
| 2.00 | X | X | X | X | X | X | X |
MINI TREK RX Size Matrix Table 2-1
The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section ending distal to the guide wire notch junction, along with brachial and femoral markers.
11.2 MINI TREK OTW Coronary Dilatation Catheter
The MINI TREK OTW Coronary Dilatation Catheter is an over-the-wire (OTW) co-axial design with a balloon at the distal tip. Table 2-2 provides a matrix of the balloon diameters and lengths available for the MINI TREK OTW family of devices.
| Table 2-2 | MINI TREK OTW Size Matrix | ||||||
|---|---|---|---|---|---|---|---|
| Balloon | |||||||
| Diameter | |||||||
| (mm) | 6mm | 8mm | 12mm | 15mm | 20mm | 25mm | 30mm |
| 1.20 | X | X | X | X | X | ||
| 1.50 | X | X | X | X | X | ||
| 2.00 | X | X | X | X | X | X | X |
The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the
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K123279 Page 3 of 9
catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.
MINI TREK II OTW Coronary Dilatation Catheter 11.3
The MINI TREK II OTW Coronary Dilatation Catheter is an over-the-wire (OTW) co-axial design with a balloon at the distal tip. Table 2-3 provides a matrix of the balloon diameters and lengths available for the MINI TREK OTW family of devices.
| Balloon
Diameter
| (mm) | Balloon Length | ||||
|---|---|---|---|---|---|
| 6mm | 8mm | 12mm | 15mm | 20mm | |
| 1.20 | X | X | X | X | X |
| 1.50 | X | X | X | X | X |
| 2.00 | X | X | X | X | X |
Table 2-3 MINI TREK II OTW Size Matrix ·
The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.
INDICATIONS FOR USE 12.
The MINI TREK RX, MINI TREK OTW and MINI TREK II OTW Coronary Dilatation Catheters (balloon models 1.50 mm - 2.00 mm) are indicated for:
- · Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion
- Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary . flow in patients with ST-segment elevation myocardial infarction
- · Balloon dilatation of a stent after implantation (balloon models 2.00 mm only)
- · Balloon dilatation of de novo chronic total coronary occlusions (CTO)
The MINI TREK RX, MINI TREK OTW and MINI TREK II OTW Coronary Dilatation Catheter s(balloon models 1.20 mm) are indicated for:
- · Initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis)
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K123279Page 4 of 9
· Balloon dilatation of de novo chronic total coronary occlusions (CTO)
TECHNOLOGICAL CHARACTERISTICS 13.
Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices.
PERFORMANCE DATA 14.
14.1 Summary of Biocompatibility Testing
Biocompatibility testing, previously conducted, included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, and complement activation according to the recommendations of Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010 and ISO 10993-1:2003, Biological evaluation of medical devices - Part 1: Evaluation and testing.
14.2 Summary of In Vitro Bench Testing
The MINI TREK RX, MINI TREK OTW and MINI TREK II OTW Coronary Dilatation Catheters were previously subjected to the following in vitro bench tests according to the requirements of Guidance for Industry and FDA Staff- Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010:
- Catheter Preparation .
- Balloon Crossing Profile ●
- Refolded Balloon Profile
- . Balloon Inflation / Balloon Deflation
- . Balloon Fatigue
- . Balloon Fatigue Within a Stent
- Balloon Rupture .
- . Balloon Rupture Within a Stent
- Balloon Compliance .
- . Catheter Shaft Fatigue
- Catheter Shaft Rupture
- . Soft Tip to Inner Member Tensile
- Proximal Balloon Seal Tensile .
- . Distal Catheter Tensile
- Catheter Coating Particulate .
- . Catheter Coating Integrity
- . Catheter Coating Friction
- Kink and Flexibility ●
- Torque .
4
- Radiopacity .
14.3 Summary of Clinical Data
The primary objective of the EXPERT CTO clinical trial is to assess the safety and effectiveness of the XIENCE V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System and the XIENCE PRIME LL Everolimus Eluting Coronary Stent System for the treatment of chronic total coronary occlusions. Another key objective of this trial is to assess the safety and effectiveness of the MINI TREK Coronary Dilatation Catheter in predilatation of chronic total occlusions.
Assessment of the MINI TREK related objective of the trial has been completed. Assessment of the MINI TREK related objective was to be performed in at least the initial 60 subjects with successful guide wire crossing, identified as confirmation of the guide wire in the distal true lumen. However, evaluable data (including core laboratory ascertained angiography data immediately following pre-dilatation with the MINI TREK Coronary Dilatation Catheter) was not available in all 60 subjects, and therefore a total analysis population of 88 subjects was reached that included 65 subjects with evaluable data for the MINI TREK related primary analysis, and 23 subjects that did not have core laboratory ascertained angiography data immediately following pre-dilatation with the MINI TREK Coronary Dilatation Catheter. In both the total analysis population (N=88) and the evaluable population (N=65), the MINI TREK Coronary Dilatation Catheter was used at first attempt for pre-dilatation of the CTO. Results are presented below for the total analysis population, as this set of results best represents the performance of the MINI TREK Coronary Dilatation Catheter in the entire intended CTO study population of the EXPERT CTO trial.
Abbott Vascular notes that assessment of the MINI TREK related objective of the EXPERT CTO trial involved analysis of only the MINI TREK Coronary Dilatation Catheter cohort (subpopulation of the full EXPERT CTO study), for only data derived from the index procedure through the in-hospital visit.
Subjects with signs and/or symptoms considered typical of ischemic heart disease attributed to a CTO in a native coronary artery, who were suitable for a percutaneous revascularization. were included. Subjects with evidence of acute MI within 72 hours of the intended treatment were excluded. The target lesion was a de novo lesion with at least one target segment in a native coronary vessel meeting the definition of chronic total occlusion. Only one target lesion was allowed to be treated.
Primary Endpoint
The angioplasty pre-dilatation related primary endpoint was successful pre-dilatation of the CTO defined as follows: (1) successful delivery of the MINI TREK Coronary Dilatation Catheter to and across the target lesion and; (2) successful inflation and deflation of the MINI TREK Coronary Dilatation Catheter and; (3) absence (as determined by independent
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' A total of 65 subjects with evaluable data were enrolled in the MINI TREK Coronary Dilatation Catheter cohort of the EXPERT CTO due to ongoing enrollment of the cohor that occurred in parallel with analyses to determine when at least 60 subjects with evaluable data had been enrolled.
5
angiographic core laboratory assessment) of clinically significant vessel perforation, flowlimiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline and clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI TREK and; (4) achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure (i.e. after stent implantation).
K123279 Pogo 6
Baseline Subject Characteristics:
The 88 subjects in the total analysis population for the angioplasty predilatation-related endpoint had a mean (±SD) age of 61.52 (±10.37) years and 76.1% (67/88) were men and 23.9% (21/88) were women. A total of 94.3% (83/88) of the subjects were dyslipidemic; 90.8% (79/87) were hypertensive and 39.8% (35/88) were diabetics with 31.4% (11/35) of the diabetic subjects requiring insulin. Cardiac history revealed prior MI in 31.0% (26/84) of the subjects and previous percutaneous coronary intervention in 45.5% (40/88). In addition, 32.2% (28/87) of the subjects had history of smoking within the last month prior to enrollment.
Baseline Target Lesion Characteristics:
A total of 88 target lesions were treated in 88 subjects in the total analysis population. Angiographic core lab data immediately post-MINI TREK pre-dilatation were available for 65 target lesions (evaluable population subset of the total analysis population), and angiographic core lab data at the end of the index procedure (i.e. after stent implantation) were available for all 88 target lesions in the total analysis population.
Of the target lesions treated in the total analysis population, 35.2% (31/88) were located in the LAD artery, 14.8% (13/88) were located in the LCX, and 50.0% (44/88) were located in the RCA. The mean (±SD) lesion length was 36.68 (±17.86) mm: one lesion (1.1%, (1/88)) was 20 mm. The mean (±SD) occlusion length was 13.82 (±8.67) mm.
Assessment of the target lesions in the total analysis population at baseline revealed moderate calcification in 20.5% (18/88) and severe calcification in 14.8% (13/88) of the lesions, and 9.2% (8/87) were eccentric and 1.1% (1/88) had thrombus.
Assessment by the angiographic core laboratory for the total analysis population included mean (±SD) pre-procedure reference vessel diameter (RVD) of 2.59 (±0.45) mm. mean (±SD) pre-procedure MLD of 0.01 (±0.03) mm, and mean (±SD) pre-procedure % diameter stenosis (DS) of 99.77 (±1.04) %. Pre-procedure TIMI flow of 0 was noted in 95.5% (84/88), and pre-procedure TIMI flow of 1 was noted in 4.5% (4/88) of the lesions in the total analysis population.
Primary Endpoint Results:
In the total analysis population (N=88), the angioplasty pre-dilatation related primary endpoint was assessed using site-reported data for the third component of the endpoint where angiographic core laboratory data was not available. This analysis yielded numerically
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K123279 Page 7 of 9
similar primary endpoint results as the primary endpoint analysis of the evaluable population only.2
The primary endpoint, successful pre-dilatation of the CTO, was achieved in 93.2% (82/88) of the 88 subjects in the total analysis population with a 95% confidence interval (CI) of [85.7%, 97.5%]. The individual criteria for successful pre-dilatation included:
-
- successful delivery of at least one MINI TREK balloon to and across the target lession in 96.6% (85/88) of the total analysis population,
-
- successful inflation and deflation with at least one MINI TREK balloon in 100.0% . (85/85)3 of the total analysis population,
-
- absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in TIMI from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following the dilatation with the MINI TREK balloon in 97.7% (86/88) of the total analysis population (with site-reported data if core lab data not available immediately following MINI TREK pre-dilatation), and
-
- final TIMI 3 flow at the conclusion of the index procedure (i.e. after stent implantation) in 98.9% (87/88) of the total analysis population.
| | Balloon
Success | 95%CI |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------|
| Angioplasty predilatation-related Endpoint | 93.2% (82/88) | [85.7%,97.5%] |
| Successful delivery of MINI TREK Coronary
Dilatation Catheter to and across target lesion1 | 96.6% (85/88) | [90.4%,99.3%] |
| Successful inflation and deflation with MINI
TREK Coronary Dilatation Catheter2 | 100.0%
(85/85) | [95.8%,100.0%] |
| Absence of clinically significant vessel
perforation, flow limiting vessel dissection,
reduction in TIMI flow from baseline or
clinically significant arrhythmias requiring
medical treatment or device intervention
following dilatation with MINI TREK3 | 97.7% (86/88) | [92.0%,99.7%] |
| Achievement of final TIMI flow 3 for the target
lesion at the conclusion of the index procedure4 | 98.9% (87/88) | [93.8%,100.0%] |
Primary Endpoint Results - Total Analysis Population Table 2-4
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2 When assessed among the evaluable subjects only (N=65), the primary endpoint of successful pre-dilatation of the CTO was achieved in 93.8% (61/65) of the evaluable subjects with a 95% Cl of [85.0%, 98.3%].
3 The denominator includes only subjects in whom inflation of the MINI TREK was attempted (i.e. subjects with successful delivery of the MINI TREK across the target lesion). A subject was considered successful for this component if at least one MINI TREK dilatation catheter was successfully inflated and deflated per the clinical site.
7
1 Data source: site-reported. A subject was considered successful for this component if at least one MINI TREK dilatation catheter was successfully delivered to and across the target lesion per the clinical site.
2 Data source: site-reported. The denominator includes only subjects in whom inflation and deflation of the MINI TREK was attempted (i.e. subjects with successful delivery of the MINI TREK across the target lesion). A subject was considered successful for this component if at least one MINI TREK dilatation catheter was successfully inflated and deflated per the clinical site
5 Data source: angiographic core laboratory for vessel perforation, flow limiting vessel dissection and reduction in TIMI from baseline (site-reported data was used if angiographic core laboratory data was not available); site-reported for clinically significant arrhythmia.
4 Data source: angiographic core laboratory.
Secondary Endpoint Results:
Device success, defined as attainment of