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

NCT01599078 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-05-15

No results posted yet for this study

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

Interventions

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Spectranetics Corporation

    collaborator INDUSTRY

  • Midwest Cardiovascular Research Foundation

    lead OTHER

Principal Investigators

  • Eric J Dippel, MD · Midwest Cardiovascular Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01599078 on ClinicalTrials.gov