Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System

This study adopts a prospective, multi-centre, randomised controlled trial design, aiming at evaluating the efficacy and safety of the BeGraft Peripheral Stent Graft System for primary iliac artery stenosis and/or occlusive lesions. A total of 182 subjects are planned to be enrolled, with all consecutively enrolled subjects being randomly assigned to an experimental group (BeGraft group, n=91) and a control group (bare metal stent group, n=91) in the ratio of 1:1 and respectively treated using the BeGraft Peripheral Stent Graft System and the bare metal stent system. Follow-up visits are carried out for the above-mentioned 182 subjects at baseline, upon discharge from hospital, at 30 days, 6 months, 12 months and then once a year from the 2nd to 5th year following surgery. A Doppler ultrasound (DUS) examination is carried out when subjects return to hospital at 6 months following surgery, and a CT angiography (CTA) examination when returning 12 months following surgery, with telephone follow-ups being conducted at 30 days and then once a year from the 2nd to 5th year following surgery.

Inclusion criteria

• Aged ≥18 years old, no restrictions in terms of male or female;
• Participating in the trial voluntarily, and having signed the informed consent form;
• TASC class A, B, C or D lesions of the common iliac artery and/or external iliac artery;
• Primary iliac atherosclerotic stenosis and/or occlusive lesions;
• Total length of lesions on the affected side ≤100 mm.

Exclusion criteria

• Expected survival period <12 months;
• Pregnant women or those unable to take effective contraceptive measures during the trial;
• Aneurysms present close to the target lesion;
• Acute or subacute thrombosis within the target vessel;
• Previously unobstructed internal iliac artery being blocked (diameter stenosis <70%) by the stented region;
• Total occlusive lesions, with the guidewire being unable to return the true lumen in the iliac artery;
• Severe calcification at the target lesion, with the catheter being unable to pass;
• Allergic to cobalt-chromium alloy (L605), ePFTE coating material, carbon coating, contrast agent, antiplatelet agents, anticoagulant drugs or presenting with contraindications;
• Total occlusion of the superficial femoral artery and deep femoral artery, with there being no outflow tract;
• Suffering from extensive diffuse disease at the distal end, resulting in poor blood flow in the outflow tract following stent placement;
• A history of coagulation disorders;
• The subject's mental state making it impossible for them to comprehend the nature, extent and possible consequences of the trial, or having a language barrier making it difficult for the subject to give their informed consent;
• Poor cooperation or potentially poor compliance with the protocol which may cause deviations during the trial.