N/A
Completed N=1,406
IN.PACT Global Clinical Study
Source: ClinicalTrials.gov NCT01609296 ↗Enrolled (actual)
1,406
Serious AEs
76.4%
Results posted
Jan 2019
Primary outcomePrimary: Clinical Cohort ITT - Primary Effectiveness Endpoint — 1263 Participants
Summary
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cohort ITT - Primary Effectiveness Endpoint |
1263 | — |
| PRIMARY Clinical Cohort ITT - Primary Safety Endpoint |
1254 | — |
| PRIMARY Imaging Cohort ITT - Primary Effectiveness Endpoint |
217 | — |
| PRIMARY 150mm DEB ITT Cohort - Primary Effectiveness Endpoint |
106 | — |
| SECONDARY Clinical Cohort ITT - MAEs |
517; 196; 342; 15; 71 | — |
| SECONDARY Clinical Cohort ITT - TLR |
338 | — |
| SECONDARY Clinical Cohort ITT - TVR |
56 | — |
| SECONDARY Clinical Cohort ITT - Device Success |
2988 | — |
| SECONDARY Clinical Cohort ITT - Clinical Success |
1376 | — |
| SECONDARY Clinical Cohort ITT - Clinically-driven TLR |
331 | — |
| SECONDARY Clinical Cohort ITT - Time to First Clinically-driven TLR (Days) |
669.2 | — |
| SECONDARY Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure. |
80.5 | — |
| SECONDARY Clinical Cohort ITT - Primary Sustained Clinical Improvement |
606 | — |
| SECONDARY Clinical Cohort ITT - Secondary Sustained Clinical Improvement |
762 | — |
| SECONDARY Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure |
1086 | — |
| SECONDARY Clinical Cohort ITT - Sustained Hemodynamic Improvement |
437 | — |
| SECONDARY Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) |
74.4 | — |
| SECONDARY Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) |
0.7629 | — |
| SECONDARY Clinical Cohort ITT - Procedural Success |
1750 | — |
| SECONDARY Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion |
111 | — |
| SECONDARY Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion |
71 | — |
| SECONDARY 150mm DEB ITT Cohort - MAEs |
47; 20; 30; 1; 3 | — |
| SECONDARY 150mm DEB ITT Cohort - Clinically-driven TLR |
28 | — |
| SECONDARY 150mm DEB ITT Cohort - TLR |
29 | — |
| SECONDARY 150mm DEB ITT Cohort - TVR |
31 | — |
| SECONDARY 150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days) |
622.2 | — |
| SECONDARY 150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure. |
81.1 | — |
| SECONDARY 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement |
62 | — |
| SECONDARY 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement |
74 | — |
| SECONDARY 150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure |
90 | — |
| SECONDARY 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement |
43 | — |
| SECONDARY 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) |
78.5 | — |
| SECONDARY 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) |
0.8278 | — |
| SECONDARY 150mm DEB ITT Cohort - Device Success |
231 | — |
| SECONDARY 150mm DEB ITT Cohort - Procedural Success |
130 | — |
| SECONDARY 150mm DEB ITT Cohort - Clinical Success |
115 | — |
| SECONDARY Clinical Cohort ITT - All-cause Mortality |
244 | — |
| SECONDARY Clinical Cohort ITT - Clinically-driven TVR |
381 | — |
| SECONDARY Clinical Clinical Cohort ITT - Clinically-driven TVR |
224 | — |
| SECONDARY Clinical Cohort ITT - Major Target Limb Amputation |
19 | — |
| SECONDARY 150mm DEB ITT Cohort - All-cause Mortality |
20 | — |
| SECONDARY 150mm DEB ITT Cohort - Clinically-driven TVR |
30 | — |
| SECONDARY 150mm DEB ITT Cohort - Major Target Limb Amputation |
1 | — |
Eligibility Criteria
General inclusion Criteria:
- Age ≥ 18 years or minimum age as required by local regulations.
- Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4.
- Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.
General exclusion Criteria:
- High probability of non-adherence to Clinical Investigation Protocol follow-up requirements.
- Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
- Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.
Data sourced from ClinicalTrials.gov (NCT01609296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.