Active — Not RecruitingNot Applicable

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

China182 participantsStarted 2019-09-19

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary patency rate

Timeframe: 12 month

Trial details

NCT IDNCT04023370

SponsorBentley InnoMed GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Iliac Artery Stenosis trials