Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting

Popliteal Artery Clinical Trial

— ETAP  

Official title:

Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions - Balloon Angioplasty Versus Primary Stenting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00712309
• Other study ID #: ETAP Protocol 2.0
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2008
• Last updated: February 9, 2009
• Start date: February 2007

Study information

• Verified date: February 2009
• Source: Herz-Zentrums Bad Krozingen
• Contact: Thomas Zeller, MD
• Phone: 004976334024350
• Email: thomas.zeller[@]herzzentrum.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Popliteal Artery

Intervention

Device:
• Lifestent
Stent for endovascular treatment of popliteal artery lesions
• balloon-angioplasty (PTA)
PTA for endovascular treatment of popliteal artery lesions

Locations

Country	Name	City	State
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Universitäres Herzzentrum Hamburg	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Herz-Zentrums Bad Krozingen	Universitätsklinikum Hamburg-Eppendorf, University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s)		12-month	No
Secondary	Primary patency		12 and 24 months	No