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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Iliac Artery Stenosis
• Intervention / Treatment: Device: Treatment of primary iliac artery stenosis and/or occlusive lesions

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 Type: Interventional
• Enrollment (Estimated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Schirling; Phone Number: 77 0049 7471984955; Email: m.schirling@bentley.global

Study Locations

• China
  • Beijing, China
    • Beijing Hospital
  • Peking, China
    • Peking University People's Hospital
  • Peking, China
    • Peking University first hospital
  • Peking, China
    • Peking University Third Hospital
  • Shanghai, China
    • Shanghai Ninth People's Hospital
  • Soochow, China
    • The Second Affiliated Hospital of Soochow University
  • Suzhou, China
    • Suzhou Municipal Hospital
  • Tianjin, China
    • The Second Hospital Of Tianjin Medical University
  • Tianjin, China
    • General Hospital of Tianjin Medical University
  • Tianjin, China
    • Tianjin First Center Hospital
  • Wuhan, China
    • The Central Hospital of Wuhan
  • Zhejiang, China
    • The First Hospital of Zhejiang Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bentley InnoMed GmbH
• Collaborators: Shanghai Micro Medical Devices Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2019
• Primary Completion (Actual): September 30, 2022
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: CT02-01 BGP-China

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No