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Balloon Angioplasty Versus Primary Stenting for the Treatment of Femoropopliteal Artery Chronic Total Occlusions

NCT01268722 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-04-06

No results posted yet for this study

Summary

This is a multicenter double-arm randomized trial investigating plain balloon angioplasty versus primary placement of self-expanding nitinol stents after endovascular recanalization of femoral CTOs. Study will recruit up to 200 patients to be adequately powered for detection of a significant difference in vessel patency after 1 year.

Conditions

  • Chronic Total Occlusion of Artery of the Extremities

Interventions

DEVICE

Balloon angioplasty

This arm will include patients randomized to undergo the treatment of a chronic total occlusion of the femoropopliteal artery with the use of balloon angioplasty

DEVICE

Primary stenting

This arm will include patients randomized to undergo primary stenting of the femoropopliteal chronic total occlusion

Sponsors & Collaborators

  • University of Patras

    lead OTHER

Principal Investigators

  • Dimitrios Siablis, MD, PhD · University Hospital of Patras

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-12-31
Completion
2016-12-31

Countries

  • Greece
  • Italy
  • United Kingdom

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 NCT01268722 on ClinicalTrials.gov