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

Study Overview
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Brief Summary
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The trial will be conducted to evaluate the safety and efficacy of the BeGraft Peripheral Stent Graft System in interventional revascularisation for subjects with primary iliac artery stenosis and/or occlusive lesions by conducting a multi-centre, randomised controlled clinical study with a bare metal stent system as the control, thus providing a basis for the formal use of the product in China

Detailed Description
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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.

Official Title
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Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System in Interventional Treatment of Revascularisation for Primary Iliac Artery Stenosis and/or Occlusive Lesions: a Prospective, Multi-centre, Randomised Controlled Clinical Study

Conditions
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Iliac Artery Stenosis

Intervention / Treatment
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* Device: Treatment of primary iliac artery stenosis and/or occlusive lesions


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multi-centre, randomised controlled trial design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BeGraft Peripheral Stent Graft System<br>Covered stent | Device: Treatment of primary iliac artery stenosis and/or occlusive lesions<br>* Stent implantation<br>|
| Active Comparator: Bare metal stent system<br>bare metal stent | Device: Treatment of primary iliac artery stenosis and/or occlusive lesions<br>* Stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency rate | The primary patency rate is defined as the absence of restenosis in the treated vessel segment without accompanying target lesion revascularisation (TLR) or amputation. | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device/Surgical success rate | Stent placement and integrity | 30 days, 6 months and 12 months following surgery, and then once a year from the 2nd to 5th year following surgery |