Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting (ETAP)

Herz-Zentrums Bad Krozingen

Status: Unknown

Conditions: Popliteal Artery

Treatments: Device: balloon-angioplasty (PTA); Device: Lifestent

Study type: Interventional

Funder types: Other

Identifiers

NCT00712309

ETAP Protocol 2.0

Details and patient eligibility

About

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?

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

1

Active Comparator group

Description:

Percutaneous transluminal angioplasty (PTA)

Treatment:

Device: balloon-angioplasty (PTA)

2

Active Comparator group

Description:

Primary stenting

Treatment:

Device: Lifestent