Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting

NCT00712309 | Unknown DMC

• 1 other identifier: ETAP Protocol 2.0
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

• 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?

Conditions

Popliteal Artery

Keywords

atherosclerotic; lesions

Outcome Measures

Primary Outcomes (1)

• Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s)

  12-month

Secondary Outcomes (1)

• Primary patency

  12 and 24 months

Study Arms (2)

1

ACTIVE COMPARATOR

Percutaneous transluminal angioplasty (PTA)

Device: balloon-angioplasty (PTA)

2

ACTIVE COMPARATOR

Primary stenting

Device: Lifestent

Interventions

Lifestent DEVICE

Stent for endovascular treatment of popliteal artery lesions

2

balloon-angioplasty (PTA) DEVICE

PTA for endovascular treatment of popliteal artery lesions

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Herz-Zentrums Bad Krozingen: lead
• University Hospital Tuebingen: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (2)

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

RECRUITING

Universitäres Herzzentrum Hamburg

Hamburg, 22527, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 25775675 DERIVED

• 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.

  PMID: 23694965 DERIVED

MeSH Terms

Interventions

Angioplasty, Balloon

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

Thomas Zeller, MD

CONTACT

004976334024350; thomas.zeller@herzzentrum.de

Aljoscha Rastan, MD

CONTACT

004976334024350; aljoscha.rastan@herzzentrum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 9, 2008
• Study Start: February 1, 2007
• Primary Completion: June 1, 2010
• Last Updated: February 10, 2009

Record last verified: 2009-02

Locations

DE (2)