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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 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. The trial reports 2 study locations across 2 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01566461
The ClinicalTrials.gov registry entry for NCT01566461 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Endovascular, which has 25 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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