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Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease

NCT00986752 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-03-07

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy of stenting after dilation with or without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral artery disease.

Conditions

  • Peripheral Vascular Diseases

Interventions

DEVICE

Stenting (Smart Stent)

Nitinol stent

DEVICE

Stenting after PEB (Smart Stent, Invatec)

Stenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB).

PROCEDURE

Atherectomy (SilverHawk device)

Atherectomy

Sponsors & Collaborators

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Adnan Kastrati, MD · Deutsches Herzzentrum München

  • Ilka Ott, MD · Klinikum rechts der Isar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2014-12-31
Completion
2015-03-31

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 NCT00986752 on ClinicalTrials.gov