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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00712309
Recruitment Status : Unknown
Verified February 2009 by Herz-Zentrums Bad Krozingen.
Recruitment status was:  Recruiting
First Posted : July 9, 2008
Last Update Posted : February 10, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief 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?

Condition or disease Intervention/treatment
Popliteal Artery Device: Lifestent Device: balloon-angioplasty (PTA)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions - Balloon Angioplasty Versus Primary Stenting
Study Start Date : February 2007
Estimated Primary Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Percutaneous transluminal angioplasty (PTA)
Device: balloon-angioplasty (PTA)
PTA for endovascular treatment of popliteal artery lesions
Active Comparator: 2
Primary stenting
Device: Lifestent
Stent for endovascular treatment of popliteal artery lesions


Outcome Measures

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

Secondary Outcome Measures :
  1. Primary patency [ Time Frame: 12 and 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712309


Contacts
Contact: Thomas Zeller, MD 004976334024350 thomas.zeller@herzzentrum.de
Contact: Aljoscha Rastan, MD 004976334024350 aljoscha.rastan@herzzentrum.de

Locations
Germany
Herzzentrum Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Thomas Zeller, MD    004976334024350    thomas.zeller@herzzentrum.de   
Principal Investigator: Thomas Zeller, MD         
Universitäres Herzzentrum Hamburg Recruiting
Hamburg, Germany, 22527
Contact: Hans Krankenberg, MD    0049408890090      
Sponsors and Collaborators
Herz-Zentrums Bad Krozingen
University Hospital Tuebingen
Universitätsklinikum Hamburg-Eppendorf