Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting. - Full Text View

Sponsors and Collaborators:	Herz-Zentrums Bad Krozingen University Hospital Tuebingen Universitätsklinikum Hamburg-Eppendorf
Information provided by:	Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier:	NCT00712309

Purpose

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

MedlinePlus related topics: Angioplasty

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions - Balloon Angioplasty Versus Primary Stenting

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:	January 2009 (Final data collection date for primary outcome measure)

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

Eligibility

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

Responsible Party:	Herzzentrums Bad Krozingen ( Thomas Zeller, MD )
Study ID Numbers:	ETAP Protocol 2.0
Study First Received:	July 8, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00712309
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 January 14, 2009