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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Midwest Cardiovascular Research Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Spectranetics Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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