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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Herz-Zentrums Bad Krozingen.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University Hospital Tuebingen
Universitätsklinikum Hamburg-Eppendorf
Information provided by:
Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier:
NCT00712309
First received: July 8, 2008
Last updated: February 9, 2009
Last verified: February 2009
History of Changes
  Purpose

  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 Intervention
Popliteal Artery
 Device: Lifestent
Device: balloon-angioplasty (PTA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions - Balloon Angioplasty Versus Primary Stenting

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Further study details as provided by Herz-Zentrums Bad Krozingen:

Primary Outcome Measures:
  • Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s) [ Time Frame: 12-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Primary patency [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: February 2007
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Thomas Zeller, MD, Herzzentrums Bad Krozingen
ClinicalTrials.gov Identifier: NCT00712309     History of Changes
Other Study ID Numbers: ETAP Protocol 2.0
Study First Received: July 8, 2008
Last Updated: February 9, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Herz-Zentrums Bad Krozingen:
atherosclerotic
lesions

ClinicalTrials.gov processed this record on May 23, 2013