IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
Completed · Not applicable
Conditions studied: Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
In brief
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.
Key facts
- Study ID
- NCT01566461
- Run by
- Medtronic Endovascular
- People needed
- 331
- Starts
- 2012-03-01
- Expected to finish
- 2018-05-01
- Last updated by the study team
- 2019-02-12
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age: > or equal to 18 years and < or equal to 85 years
- Documented ischemia with Rutherford classification 2, 3, or 4
- Target lesion in the SFA and/or PPA
- Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria:
- 70 - 99% occlusion by visual estimate with lesion length > or equal to 4 cm and < or equal to 18 cm
- 100% occlusion by visual estimate with lesion length < or equal to 10 cm
- Combination lesions must have a total lesion length of > or equal to 4 cm and < or equal to 18 cm with an occluded segment that is < or equal to 10 cm (by visual estimate)
- Target vessel diameter > or equal to 4 mm and < or equal to 7 mm
- Angiographic evidence of adequate distal run-off to the ankle
- Able to walk without assistive devices
You may not qualify if…
- Stroke or heart attack within 3 months prior to enrollment
- Enrolled in another investigational drug, device or biologic study
- Any surgical procedure or intervention performed within 30 days prior to or post index procedure
- SFA or PPA disease in the opposite leg that requires treatment at the index procedure
- Failure to successfully cross the target lesion
- Angiographic evidence of severe calcification
- Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices)
- Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
- Chronic kidney disease
Where it is running
- Washington Hospital — Fremont, California, United States
- Kaiser Permanente Hawaii — Honolulu, Hawaii, United States
Full record on ClinicalTrials.gov
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