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Standard Balloon Angioplasty Versus Angioplasty With a Paclitaxel-eluting Balloon for Femoral Artery In-stent Restenosis

NCT01305070 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2015-02-06

No results posted yet for this study

Summary

Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral, Invatec).

Conditions

  • Peripheral Vascular Disease

Interventions

DEVICE

Admiral Xtreme

For balloon angioplasty of in-stent restenosis in the superficial femoral artery

DEVICE

In.Pact Admiral

For balloon angioplasty of in-stent restenosis in the superficial femoral artery

Sponsors & Collaborators

  • Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

    lead OTHER

Principal Investigators

  • Hans Krankenberg, MD · Medical Care Center Prof. Mathey, Prof. Schof Ltd.

  • Thilo Tübler, MD · Medical Care Center Prof. Mathey, Prof. Schofer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-12-31
Completion
2013-06-30

Countries

  • Germany

Study Locations

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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 NCT01305070 on ClinicalTrials.gov