Status:
WITHDRAWN
Local Paclitaxel Delivery to Prevent Restenosis in Peripheral Arterial Disease
Lead Sponsor:
Jane Phillips Medical Center
Conditions:
Peripheral Arterial Disease
Restenosis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to determine if the addition of a catheter-based local delivery of paclitaxel into the peripheral arterial vessels in patients with peripheral arterial disease (PAD) and s...
Detailed Description
Peripheral arterial disease (PAD) of the lower extremities is an extremely prevalent, and often times, disabling disorder reaching roughly 8 million people in the United States, and up to 20 percent o...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Rutherford Stages 2-5 plus prior history of endovascular revascularization and recurrent stenosis (in stent, post angioplasty, post atherectomy) (Table 1 )
- one or more restenotic lesions within the SFA of at least 70% of the vessel diameter
- Successful percutaneous revascularization of the femoropopliteal artery (\< 20% residual stenosis by visual estimate) using standard techniques per discretion of the local operator
- The femoropopliteal Reference Vessel Diameter (RVD) must be ≥4.0 mm and ≤7.0 mm
Exclusion
- Patient is pregnant or breast feeding. (Female subjects of childbearing potential must have negative serum pregnancy test the day of the procedure.)
- Life expectancy \< 12 months.
- Contraindication to aspirin, clopidogrel or other thienopyridine, heparin, low molecular weight heparin, bivalirudin or other therapies required for procedure or follow up.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- Known allergy to paclitaxel.
- Uncontrolled hypercoagulability or history of HIT or HITTS syndrome.
- Simultaneous enrollment in another investigational device or drug study.
- Absence of at least 1 TIMI-3 vessel run off into the foot.
- Platelet count \< 100,000/mm3.
- White blood cell count \< 1.5/mm3.
- Any evidence of perforation or dye extravasation during the index procedure, even if successfully treated with a covered stent.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03858764
Start Date
August 1 2013
End Date
August 1 2013
Last Update
March 4 2019
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