MedTrace Logo

Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis

NCT01083030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-05-06

No results posted yet for this study

Summary

The aim of the study is correlating efficacy of the treatment to the proportion of paclitaxel-dose supplied by the catheter. Forty-five patients each will be treated by paclitaxel-coated or uncoated conventional balloon catheters in randomized order in 3 study centers. Main inclusion criteria are Rutherford class 2 - 5, ≥70% stenosis or occlusion in the superficial femoral or popliteal artery, main exclusion criteria are related to the use of paclitaxel and the need for follow-up examinations. Either clinical or angiographic follow-up examinations are planned 6, 12 and 24 months following the intervention. Primary endpoint is 6-month angiographic late lumen loss. Secondary endpoints are further angiographic and clinical efficacy and various safety criteria.

Conditions

Interventions

DEVICE

Percutaneous transluminal angioplasty (PTA)

Angioplasty of superficial femoral artery (SFA)

COMBINATION_PRODUCT

DCB

Drug Coated Balloon Angioplasty

Sponsors & Collaborators

  • University Hospital, Saarland

    lead OTHER

Principal Investigators

  • Michael Werk, MD · Martin-Luther-Hospital Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-08-31
Completion
2012-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT01083030 on ClinicalTrials.gov