Clinical trial NCT04023370: Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Iliac Artery Stenosis
Lead sponsor: Bentley InnoMed GmbH
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Micro Medical Devices Co., Ltd.
First posted: 2019-07-17
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multi-centre, randomised controlled trial design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary patency rate
timeFrame: 12 month
Secondary outcomes:
measure: Device/Surgical success rate
timeFrame: 30 days, 6 months and 12 months following surgery, and then once a year from the 2nd to 5th year following surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
city: Peking
country: China
facility: Peking University First Hospital
city: Peking
country: China
facility: Peking University People's Hospital
city: Peking
country: China
facility: Peking University Third Hospital
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
city: Soochow
country: China
facility: The Second Affiliated Hospital of Soochow University
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Tianjin
country: China
facility: Tianjin First Center Hospital
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
city: Zhejiang
country: China
facility: The First Hospital of Zhejiang Province
Study officials:
References: