Recruiting

Paclitaxel

Sponsor:

Midwest Cardiovascular Research Foundation

Code:

NCT01599078

Conditions

Restenosis

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paclitaxel

Placebo

Study Details

Brief 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.

Conditions

Restenosis

Peripheral Arterial Disease

Study ID

NCT01599078

Start date

Jan, 2012

Status verified date

May, 2012

Completion date

Jan, 2014

Anticipated

Primary completion date

Jan, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

active comparator: Paclitaxel

Interventions

Paclitaxel

Drug dosing is 3mcg/mm3 of artery treated with percutaneous revascularization. Drug will be administered via the TAPAS catheter and allowed to dwell for 5 minutes.

Placebo

Saline will be administered intra-arterially via the TAPAS catheter following percutaneous revascularization. The dwell time will be 5minutes.

Primary outcome measure

  • Primary Patency [ Time Frame: 6 months ]
  • Primary Safety [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Eric J Dippel, MD

563-324-2828dippel@cvmedpc.com

Locations

Trinity Medical Center

Recruiting

Bettendorf, Iowa, United States, 52722

Contacts

Eric J Dippel, MD

563-324-2828dippel@cvmedpc.com

Principal Investigator:

Eric J Dippel, MD

More Information

Sponsor

Midwest Cardiovascular Research Foundation

Last update posted

May 15, 2012

Last verified

May, 2012

Keywords

  • Restenosis
  • Angioplasty
  • Stent
  • Atherectomy
  • Femoral Artery
  • Popliteal Artery
  • Paclitaxel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Midwest Cardiovascular Research Foundation on 2012-05-15.