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NCT01566461 · ClinicalTrials.gov registry record · NA
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
A NA study of Popliteal Artery Stenosis and Femoral Artery Stenosis, sponsored by Medtronic Endovascular.
- Completed
- Registry status
- NA
- Development phase
- 331
- Enrollment target
- 2
- Study locations
NCT01566461: Completed NA study of Popliteal Artery Stenosis and Femoral Artery Stenosis, sponsored by Medtronic Endovascular.
NCT01566461 is a NA study of Popliteal Artery Stenosis and Femoral Artery Stenosis that has completed, run by Medtronic Endovascular. The registered enrollment target is 331 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01566461, a NA study of Popliteal Artery Stenosis and Femoral Artery Stenosis, has completed, sponsored by Medtronic Endovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 331 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.
Primary Outcome
Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.
Conditions Studied
Interventions
- DEVICE Drug-Coated Balloon (DCB)
- DEVICE PTA Balloon: Balloon Angioplasty
Study Locations (2)
California
- Washington Hospital - Fremont
Hawaii
- Kaiser Permanente Hawaii - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2012-03 |
| Est. Completion | 2018-05 |
| Phase | NA |
What the finished NCT01566461 record still lists
NCT01566461 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower).
The record links to 4 conditions, with Popliteal Artery Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Drug-Coated Balloon (DCB) is the first listed.
NCT01566461 reports a single indexed study location in California, Hawaii.
Frequently Asked Questions
What is clinical trial NCT01566461 about?
NCT01566461 is a clinical study titled "IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)". The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.
What is the current status of trial NCT01566461?
This trial is currently completed. It is a NA study. The enrollment target is 331 participants. The study started on 2012-03. Estimated completion is 2018-05.
What conditions does trial NCT01566461 study?
This clinical trial studies the following conditions: Popliteal Artery Stenosis, Femoral Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion.
What interventions are being tested in trial NCT01566461?
The interventions under investigation include: Drug-Coated Balloon (DCB) (DEVICE), PTA Balloon: Balloon Angioplasty (DEVICE).
Who is sponsoring clinical trial NCT01566461?
This trial is sponsored by Medtronic Endovascular, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01566461 being conducted?
This trial has 2 study locations across California, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01566461's enrollment target sits among peer trials
331 307th of 2000 higher than 1,694 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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