N/A
Completed N=150
Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
Peripheral Arterial Disease (PAD)
Source: ClinicalTrials.gov NCT01175850 ↗
Enrolled (actual)
150
Serious AEs
49.6%
Results posted
Oct 2015
Primary outcomePrimary: Primary Patency — 82.2; 52.4 Percentage of participants — p=<0.001
Summary
The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Patency |
82.2; 52.4 | <0.001 sig |
| PRIMARY Primary Safety Composite |
95.7; 76.6 | <0.001 sig |
| SECONDARY Major Adverse Events (MAE) Composite |
6.3; 24.3 | <0.001 sig |
| SECONDARY All-cause Death |
1.9; 0.0 | 0.926 |
| SECONDARY Target Vessel Revascularization (TVR) |
4.8; 23.4 | <0.001 sig |
| SECONDARY Target Lesion Revascularization (TLR) |
2.9; 20.6 | <0.001 sig |
| SECONDARY Time to First Clinically Driven Target Lesion Revascularization (CD-TLR) |
144.6; 201.9 | 0.859 |
| SECONDARY Major Target Limb Amputation |
0; 0 | >0.999 |
| SECONDARY Thrombosis at the Target Lesion |
1.4; 3.7 | 0.096 |
| SECONDARY Primary Sustained Clinical Improvement |
85.2; 68.9 | <0.001 sig |
| SECONDARY Secondary Sustained Clinical Improvement |
89.3; 84.6 | 0.121 |
| SECONDARY Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4). |
16.5; 33.7 | 0.001 sig |
| SECONDARY Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio >3.4). |
7.3; 21.4 | <0.001 sig |
| SECONDARY Change From Baseline in Quality of Life Assessment by EuroQol Group 5-Dimension Self Report Questionnaire (EQ5D) at Month 12 |
0.1059; 0.0730 | 0.095 |
| SECONDARY Change From Baseline in Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ) at 12 Months |
72.7; 73.6 | 0.590 |
| SECONDARY Device Success |
99.0; 98.5 | 0.302 |
| SECONDARY Procedural Success |
99.5; 98.2 | 0.111 |
| SECONDARY Clinical Success |
99.1; 97.3 | 0.103 |
| SECONDARY Days of Hospitalization Due to the Index Lesion |
1.3; 1.7 | 0.049 sig |
Eligibility Criteria
General Inclusion Criteria:
- Age ≥18 years and ≤85 years
- Patient or patient's legal representative is informed of the nature of the study, agrees to participate and has signed an EC approved consent form
Angiographic Inclusion Criteria:
- Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee)
General Exclusion Criteria:
- Patient unwilling or unlikely to comply with follow-up schedule
- Stroke or STEMI within 3 months prior enrolment
Angiographic Exclusion Criteria:
- Acute or sub-acute thrombus in the target vessel
Data sourced from ClinicalTrials.gov (NCT01175850). 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.