Local Delivery of Paclitaxel Via the TAPAS Catheter to Prevent Restenosis From Percutaneous Femor… (NCT01599078) | Clinical Trial Compass
UnknownNot Applicable
Local Delivery of Paclitaxel Via the TAPAS Catheter to Prevent Restenosis From Percutaneous Femoropopliteal Intervention
United States100 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.