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

May 13, 2012 updated by: Eric J Dippel, MD, Midwest Cardiovascular Research Foundation

Local Delivery of Paclitaxel Via the TAPAS Catheter to Prevent Restenosis From Percutaneous Femoropopliteal Intervention (PacTAP Study): A Double Blind, Randomized Control Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Peripheral artery disease (PAD) of the lower extremities is an extremely prevalent disorder and is an important cause of morbidity that affects more than 10 million people in the United States. This disorder is typically caused by atherosclerosis that limits blood flow to the limbs, particularly due to stenosis or occlusion of the superficial femoral artery (SFA) and/or popliteal artery. Although many patients are asymptomatic or are treated with lifestyle changes, such as exercise therapy, or pharmacological treatment, including statins and anti-platelet therapy, about 10-15% of patients have progressive symptoms which in severe cases may lead to amputation.

Endovascular treatment with percutaneous vascular intervention (PVI), which includes percutaneous transluminal angioplasty (PTA), stenting, atherectomy and thrombolytic therapy, can provide excellent acute success rates greater than 90-95% However, the intermediate to long-term patency rates of these arteries is hampered by neointimal hyperplasia resulting in restenosis of the artery. This occurs with all endovascular therapy to some degree in both the coronary and peripheral arena. With PVI in the superficial femoral and popliteal arteries the restenosis rates are approximately 30-40% at 12 months, depending on the complexity and severity of the disease.

In the coronary field, stents are now coated with anti-restenotic pharmacologic agents (drug eluting stents-DES) such as paclitaxel and sirolimus-like drugs that prevent neointimal growth. There have been published reports of significant efficacy in preventing restenosis in the SFA by coating balloons with paclitaxel (drug eluting balloons-DEB) as well as a nitinol stent. Despite the fact that these products are CE Mark approved and available in Europe, currently there are no US FDA approved drug-eluting devices for use in PVI. Thus, there remains a need for an alternative therapy to prevent restenosis in the SFA following endovascular intervention.

Administration of intra-arterial paclitaxel mixed with iodinated contrast has been shown to inhibit restenosis in a porcine coronary model.

Delivering paclitaxel intra-arterially in the coronary tree following stent implantation has shown benefit in reducing the incidence of restenosis. The novel Targeted Adjustable Pharmaceutical Application System (TAPAS)-TAPAS Catheter Therapeutic Infusion System (ThermopeutiX, San Diego, CA, USA)-is a drug delivery catheter that consists of a proximal and distal occlusion balloon with an adjustable length that allows a drug to dwell in a specific segment of the artery for a period of time. The drug can then be aspirated and discarded to avoid systemic exposure.

The PacTAP study is a randomized, double blind, placebo-control study to assess the safety and efficacy of delivering intra-arterial paclitaxel via the TAPAS catheter following PVI to prevent restenosis.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Recruiting
        • Trinity Medical Center
        • Contact:
        • Principal Investigator:
          • Eric J Dippel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Saline will be administered intra-arterially via the TAPAS catheter following percutaneous revascularization. The dwell time will be 5minutes.
Active Comparator: Paclitaxel
Drug: 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.
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Patency
Time Frame: 6 months
Loss of primary patency will occur for any clinically driven Target Lesion Revascularization (TLR) or a Peak Systolic Velocity Ratio (PSVR) of > 2.5 on Duplex Ultrasound (DUS)
6 months
Primary Safety
Time Frame: 30 days
Freedom from death, major amputation in the target limb, or Target Lesion Revascularization (either surgical or endovascular)
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Patency at 12 months
Time Frame: 12 months
Loss of primary patency will occur for any clinically driven Target Lesion Revascularization (TLR) or a Peak Systolic Velocity Ratio (PSVR) of > 2.5 on Duplex Ultrasound (DUS)
12 months
Primary Assisted Patency
Time Frame: 6 and 12 months
Patency of the target vessel regardless of secondary interventions performed to restore blood flow after restenosis.
6 and 12 months
Secondary Patency
Time Frame: 6 and 12 months
Patency of the target vessel regardless of secondary interventions performed to restore blood flow after reocclusion.
6 and 12 months
Functional Status
Time Frame: 30 days, 6 months, and 12 months
Walking Impairment Questionnaire (WIQ), and Rutherford Classification.
30 days, 6 months, and 12 months
Secondary Safety
Time Frame: 30 days, 6 months, and 12 months
Any adverse events associated with the use of paclitaxel, such as, but not limited to: hypotension, anaphylactic reactions, nausea, vomiting, diarrhea, pancytopenia, neuropathy, alopecia.
30 days, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Cardiovascular Research Foundation

Collaborators

Spectranetics Corporation

Investigators

  • Principal Investigator: Eric J Dippel, MD, Midwest Cardiovascular Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

May 13, 2012

First Submitted That Met QC Criteria

May 13, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 13, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCRF-001-EJD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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