Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting (ETAP)
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|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
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?
|Condition or disease||Intervention/treatment|
|Popliteal Artery||Device: Lifestent Device: balloon-angioplasty (PTA)|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: 1
Percutaneous transluminal angioplasty (PTA)
Device: balloon-angioplasty (PTA)
PTA for endovascular treatment of popliteal artery lesions
Active Comparator: 2
Stent for endovascular treatment of popliteal artery lesions
- Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s) [ Time Frame: 12-month ]
- Primary patency [ Time Frame: 12 and 24 months ]
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
|Contact: Thomas Zeller, MDemail@example.com|
|Contact: Aljoscha Rastan, MDfirstname.lastname@example.org|
|Herzzentrum Bad Krozingen||Recruiting|
|Bad Krozingen, Germany, 79189|
|Contact: Thomas Zeller, MD 004976334024350 email@example.com|
|Principal Investigator: Thomas Zeller, MD|
|Universitäres Herzzentrum Hamburg||Recruiting|
|Hamburg, Germany, 22527|
|Contact: Hans Krankenberg, MD 0049408890090|