Local Delivery of Paclitaxel Via the TAPAS Catheter to Prevent Restenosis From Percutaneous Femoropopliteal Intervention

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Restenosis, Peripheral Arterial Disease

In brief

The purpose of this study is to assess the safety and efficacy of administering intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following percutaneous revascularization to prevent restenosis.

Key facts

Study ID

NCT01599078

Run by

Midwest Cardiovascular Research Foundation

People needed

100

Starts

2012-01-01

Expected to finish

2014-01-01

Last updated by the study team

2012-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old.
• Subject able to provide informed consent and agree to all follow up requirements.
• Peripheral arterial disease with Rutherford Class 2-5.
• 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

You may not qualify if…

• 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, anti-platelet/anti-coagulant therapies required for procedure/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.
• Previous intervention of the target limb with a drug eluting stent or drug eluting balloon.
• Absence of at least 1 TIMI-3 vessel run off into the foot.
• Total bilirubin > 2x upper limit of normal (ULN).
• ALT or AST > 3x ULN.
• 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.

Where it is running

• Trinity Medical Center — Bettendorf, Iowa, United States (enrolling)

Full record on ClinicalTrials.gov

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