Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting (ETAP)

February 9, 2009 updated by: Herz-Zentrums Bad Krozingen

Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions - Balloon Angioplasty Versus Primary Stenting

  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?

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bad Krozingen, Germany, 79189
      • Hamburg, Germany, 22527
        • Recruiting
        • Universitäres Herzzentrum Hamburg
        • Contact:
          • Hans Krankenberg, MD
          • Phone Number: 0049408890090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient is at least 21 years old
  • The patient or legal representative provided written informed consent
  • The patient agrees to comply with the protocol-mandated follow-up visits and testing regime
  • The patient has lifestyle-limiting claudication or critical limb ischemia defined as: Fontaine stage IIa-IV/ Rutherford 1-5 category
  • The target lesion located within the popliteal artery has angiographic evidence of stenosis > 70% or occlusion (by visual estimate)
  • At least one vessel runoff to the foot
  • The patient has no other relevant inflow or outflow stenosis (> 50%), however when needed iliac or femoral intervention may be done during study procedure.

Exclusion Criteria:

  • The patient is currently participating in a drug or another device study.
  • The popliteal artery target lesion has previously been subintimal recanalized
  • The patient has a history of bleeding diatheses or coagulopathy
  • Female patients that are pregnant
  • The patient has a contraindication (including allergic reaction) to platelet aggregation inhibitors or heparin
  • The patient is unable to conform to the study protocol follow-up procedures or visits.
  • The patient has a life expectancy of <24 months
  • The patient has concomitant renal failure which requires dialysis
  • The patient has a contraindication (including allergic reaction) to or a known sensitivity to contrast media
  • The duplex ultrasound/angiography of the target lesion must NOT meet the following criteria:

    • The popliteal artery target lesion stenosis/occlusion is also continuously located within the superficial femoral artery and/or tibiofibular tract
    • The popliteal artery target lesion is restenotic
    • The popliteal artery has been subintimal recanalized

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Percutaneous transluminal angioplasty (PTA)
PTA for endovascular treatment of popliteal artery lesions
Active Comparator: 2
Primary stenting
Stent for endovascular treatment of popliteal artery lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s)
Time Frame: 12-month
12-month

Secondary Outcome Measures

Outcome Measure
Time Frame
Primary patency
Time Frame: 12 and 24 months
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • ETAP Protocol 2.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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