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

• Status: Unknown status
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Midwest Cardiovascular Research Foundation
• Collaborator: Spectranetics Corporation
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.