Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting (ETAP)
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712309
|Contact: Thomas Zeller, MDfirstname.lastname@example.org|
|Contact: Aljoscha Rastan, MDemail@example.com|
|Herzzentrum Bad Krozingen||Recruiting|
|Bad Krozingen, Germany, 79189|
|Contact: Thomas Zeller, MD 004976334024350 firstname.lastname@example.org|
|Principal Investigator: Thomas Zeller, MD|
|Universitäres Herzzentrum Hamburg||Recruiting|
|Hamburg, Germany, 22527|
|Contact: Hans Krankenberg, MD 0049408890090|