MedTrace Logo

Paclitaxel Balloon Versus Standard Balloon in In-stent Restenoses of the Superficial Femoral Artery (PACUBA I Trial)

NCT01247402 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-12-09

No results posted yet for this study

Summary

Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial, in which consecutive patients candidates for percutaneous intervention of angioplasty to treat symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will be assigned to one of two study arms:

1. Treatment Arm: Paclitaxel eluting percutaneous transluminal angioplasty (PePTA)
2. Control Arm: standard percutaneous transluminal angioplasty (sPTA).

Purpose:

To evaluate the morphologic and clinical efficacy of Paclitaxel eluting percutaneous transluminal angioplasty (PePTA) for the reduction of restenosis in SFA and PA stents compared to standard percutaneous transluminal angioplasty (sPTA).

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

drug eluting balloon angioplasty

3 microgram Paclitaxel/mm2 on balloon, 60s application

DEVICE

standard balloon angioplasty

standard balloon angioplasty

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Johannes Lammer, MD · Medical Univerity Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • Austria

Study Locations

More Related Trials

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 NCT01247402 on ClinicalTrials.gov