CLINICAL TRIAL PROTOCOL SUMMARY / SYNOPSIS

Phase: IV

TITLE OF STUDY

Angioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised controlled trial for patients with complex lesions of the superficial femoral artery

CONDITION

Peripheral arterial occlusive disease (PAOD)

OBJECTIVE(S)

The objective of this study is to evaluate the safety and efficacy of two therapeutic strategies (operative versus endovascular) in the treatment of patients with complex atherosclerotic lesions of the superficial femoral artery.

INTERVENTIONS

Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available).

Duration of intervention per patient: Dependent on the method of treatment

Follow-up per patient: 24 months

OUTCOMES

Primary efficacy endpoint:

Two primary efficacy endpoints will be considered simultaneously in this trial:

(A) Event-free survival (time-to-event endpoint): Proportion (over the course of time) of surviving patients who show a continuing clinical improvement of >= 1 class (Rutherford classification) without the need for repeated target lesion revascularization (TLR).

(B) Proportion of surviving patients with clinical improvement of >= 1 class (Rutherford classification) at 24 months after primary intervention (regardless any performed re-intervention).

Inclusion Criteria:

• Patient is able to verbally acknowledge and understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document.
• Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol.
• Age ≥ 50 and ≤ 85 years old.
• Intermittent claudication (IC) class 2 or 3 (Rutherford) assessed by treadmill testing or 6-Minute Walk Test.
• Lasting >3 months.
• Failed conservative therapy and the patient's desire for further treatment.
• Atherosclerotic single or multiple stenoses (>50%) or an occlusion of the Superficial Femoral Artery (SFA) with a target lesion length of 10-20 cm without involvement of the common/deep femoral artery and/or the popliteal artery confirmed by duplex ultrasound and angiography.
• At least one patent tibioperoneal artery with no stenosis >50% in diameter. Technical and morphological accessibility for both catheter intervention and bypass surgery.
• Absence of other disease that would limit exercise (e.g. angina or chronic respiratory disease).

Exclusion Criteria:

• >50% stenosis or occlusion of the iliac, the common, the deep femoral or the popliteal artery.
• Surgical reconstruction or catheter intervention on the index leg within the last six months.
• Unsuitability of treadmill testing / Six-Minute Walk Test. Chronic limb ischemia (intermittent claudication class 2 to 6) on the contralateral leg.
• Known allergy to contrast agents containing iodine.
• Contraindication for antiplatelet agents or anticoagulants.
• Clinically manifested heart insufficiency (NYHA III, IV) and/or uncorrected hyperthyreosis.
• Serious general disease state with an estimated life expectancy < 2 years (ASA IV, V).
• Pregnancy

Patients with Intermittent Claudication, due to complex lesions of the superficial femoral artery