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Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting

NCT00712309 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2009-02-10

No results posted yet for this study

Summary

1. Does primary stenting have a lower 12-month restenosis rate than PTA alone in the treatment of atherosclerotic lesions of the popliteal artery?

* Alternative hypothesis: "Primary stenting with the Edwards LifeStent is associated with a lower restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery at 12 months"
* Null hypothesis: "Primary stenting with the Edwards LifeStent is not associated with a lower 12-month restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery""
2. Does comparison of the two intervention groups (PTA alone, stenting) disclose differences in terms of the secondary endpoints?
3. How do the intervention methods compare in terms of safety/incidence of adverse effects?
4. What are the long-term clinical implications of the two treatment methods?

Conditions

  • Popliteal Artery

Interventions

DEVICE

Lifestent

Stent for endovascular treatment of popliteal artery lesions

DEVICE

balloon-angioplasty (PTA)

PTA for endovascular treatment of popliteal artery lesions

Sponsors & Collaborators

  • University Hospital Tuebingen

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER

  • Herz-Zentrums Bad Krozingen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-06-30

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 NCT00712309 on ClinicalTrials.gov