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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Bentley InnoMed GmbH
- Enrollment
- 182
- Locations
- 12
- Primary Endpoint
- Primary patency rate
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Primary patency rate
Time Frame: 12 month
The primary patency rate is defined as the absence of restenosis in the treated vessel segment without accompanying target lesion revascularisation (TLR) or amputation.
Secondary Outcomes
- Device/Surgical success rate(30 days, 6 months and 12 months following surgery, and then once a year from the 2nd to 5th year following surgery)