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

Iliac Artery Stenosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04023370
• Other study ID #: CT02-01 BGP-China
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 19, 2019
• Est. completion date: August 31, 2025

Study information

• Verified date: June 2023
• Source: Bentley InnoMed GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: August 31, 2025
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Iliac Artery Stenosis

Intervention

Device:
• Treatment of primary iliac artery stenosis and/or occlusive lesions
Stent implantation

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing
China	Peking University First Hospital	Peking
China	Peking University People's Hospital	Peking
China	Peking University Third Hospital	Peking
China	Shanghai Ninth People's Hospital	Shanghai
China	The Second Affiliated Hospital of Soochow University	Soochow
China	Suzhou Municipal Hospital	Suzhou
China	General Hospital of Tianjin Medical University	Tianjin
China	The Second Hospital of Tianjin Medical University	Tianjin
China	Tianjin First Center Hospital	Tianjin
China	The Central Hospital of Wuhan	Wuhan
China	The First Hospital of Zhejiang Province	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Bentley InnoMed GmbH	Shanghai Micro Medical Devices Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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