- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00712309
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
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""
- Does comparison of the two intervention groups (PTA alone, stenting) disclose differences in terms of the secondary endpoints?
- How do the intervention methods compare in terms of safety/incidence of adverse effects?
- What are the long-term clinical implications of the two treatment methods?
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Thomas Zeller, MD
- Phone Number: 004976334024350
- Email: thomas.zeller@herzzentrum.de
Study Contact Backup
- Name: Aljoscha Rastan, MD
- Phone Number: 004976334024350
- Email: aljoscha.rastan@herzzentrum.de
Study Locations
-
-
-
Bad Krozingen, Germany, 79189
- Recruiting
- Herzzentrum Bad Krozingen
-
Contact:
- Thomas Zeller, MD
- Phone Number: 004976334024350
- Email: thomas.zeller@herzzentrum.de
-
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.
Sponsor
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.
General Publications
- Rastan A, Krankenberg H, Baumgartner I, Blessing E, Muller-Hulsbeck S, Pilger E, Scheinert D, Lammer J, Beschorner U, Noory E, Neumann FJ, Zeller T. Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial. J Endovasc Ther. 2015 Feb;22(1):22-7. doi: 10.1177/1526602814564386.
- Rastan A, Krankenberg H, Baumgartner I, Blessing E, Muller-Hulsbeck S, Pilger E, Scheinert D, Lammer J, Gissler M, Noory E, Neumann FJ, Zeller T. Stent placement versus balloon angioplasty for the treatment of obstructive lesions of the popliteal artery: a prospective, multicenter, randomized trial. Circulation. 2013 Jun 25;127(25):2535-41. doi: 10.1161/CIRCULATIONAHA.113.001849. Epub 2013 May 21.
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
Keywords
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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-
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-
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Medtronic EndovascularCompletedPopliteal Artery Stenosis | Popliteal Artery Occlusion | Femoral Artery Occlusion | Femoral Artery StenosisUnited States
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C. R. BardTerminatedPopliteal Artery Stenosis | Popliteal Artery Occlusion | Femoral Artery Occlusion | Femoral Artery StenosisUnited States
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