Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting

NCT ID: NCT00712309

Last Updated: 2009-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28

Brief Summary

1. 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""

2. Does comparison of the two intervention groups (PTA alone, stenting) disclose differences in terms of the secondary endpoints?

3. How do the intervention methods compare in terms of safety/incidence of adverse effects?

4. What are the long-term clinical implications of the two treatment methods?

Conditions

Popliteal Artery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Percutaneous transluminal angioplasty (PTA)

Group Type: ACTIVE_COMPARATOR

balloon-angioplasty (PTA)

Intervention Type: DEVICE

PTA for endovascular treatment of popliteal artery lesions

2

Primary stenting

Group Type: ACTIVE_COMPARATOR

Lifestent

Intervention Type: DEVICE

Stent for endovascular treatment of popliteal artery lesions

Interventions

Lifestent

Stent for endovascular treatment of popliteal artery lesions

Intervention Type: DEVICE

balloon-angioplasty (PTA)

PTA for endovascular treatment of popliteal artery lesions

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

Herz-Zentrums Bad Krozingen

OTHER

Sponsor Role: lead

Responsible Party

Herzzentrums Bad Krozingen

Locations

Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

Site Status: RECRUITING

Universitäres Herzzentrum Hamburg

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Thomas Zeller, MD

Role: CONTACT

thomas.zeller@herzzentrum.de

004976334024350

Aljoscha Rastan, MD

Role: CONTACT

aljoscha.rastan@herzzentrum.de

004976334024350

Facility Contacts

Thomas Zeller, MD

Role: primary

thomas.zeller@herzzentrum.de

004976334024350

Hans Krankenberg, MD

Role: primary

0049408890090

References

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.

Reference Type: DERIVED

PMID: 25775675 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23694965 (View on PubMed)

Other Identifiers

ETAP Protocol 2.0

Identifier Type: -

Identifier Source: org_study_id