Trials / Completed
CompletedNCT01609296
IN.PACT Global Clinical Study
The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,535 (actual)
- Sponsor
- Medtronic Endovascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death. The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IN.PACT Admiral™ Drug Eluting Balloon | IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon. |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2016-04-01
- Completion
- 2020-01-17
- First posted
- 2012-05-31
- Last updated
- 2021-03-25
- Results posted
- 2019-01-28
Locations
65 sites across 27 countries: Argentina, Australia, Austria, Belgium, Canada, Colombia, Czechia, Egypt, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01609296. Inclusion in this directory is not an endorsement.