A PROSPECTIVE, MULTICENTER, SINGLE-ARM TRIAL FOR THE NEW SIZES OF BRIDGE STENTS FOR VERTEBRAL ARTERY STENOSIS: Bridge-MAX

Aprospective, multicentre, single-arm clinical trial in which approximately 36 subjects would be enrolled using the Bridge 4.5 mm and 5.0 mm stent in accordance with the inclusion and exclusion criteria in this protocol. The success rate of immediate post-procedure stent target lesion treatment was recorded for all subjects, and the incidence of in-stent restenosis (≥50% stenosis) was assessed by DSA imaging follow-up at 6 months (±30 days) post-procedure. The subjects were also followed up at 30 days (±7 days), 6 months (±30 days), and 12 months (±60 days) after stent implantation to assess safety events during the follow-up period. .

Study Overview

• Status: Recruiting
• Conditions: Brain Diseases; Vertebral Artery Stenosis; Vertebral Artery Thrombosis
• Intervention / Treatment: Device: Bridge

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huina Lu; Phone Number: 15901703529; Email: HuiNa.Lu@microport.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tiantan Hospital Affilicated to Captical Medical University
    • Contact: Ning Ma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 years or above (including 18 years old), 80 years old below (including 80 years old), male or women with pregnancy test (-); 2. Symptomatic vertebral artery stenosis patients who have failed in medical treatment (defined as patients who have suffered from stroke or TIA within 90 days, and are taking at least one antithrombotic drugs as well as interventions in other vascular risks, such as hypertension and hyperlipidemia decompression or lipid reducing); 3. DSA angiography showed target lesion stenosis degree ≥70% (Stenosis degrees are determined according to WASID method); 4. Diameter of normal blood vessels distal to the target lesion ≥3.5mm and the length of target lesion ≤23mm; 5. Modified Rankin score <3; 6. Patients who are suitable for implantation of rapamycin target eluting vertebral artery stent and are voluntary to

Exclusion Criteria:

• Presence of tandem stenotic lesions (≥50% tandem stenosis) in the target lesion area; (2) TIA or non-disabling stroke due to factors other than vertebral artery stenosis (e.g. atrial fibrillation, etc.); (3) Previous surgical treatment or endovascular intervention in the target lesion area; (4) Comorbid severe systemic systemic diseases or other diseases with a potential risk of sudden death, or subjects with a life expectancy of <1 year; (5) Subjects with contraindications to heparin, aspirin, clopidogrel, or other antiplatelet drugs and who cannot tolerate anticoagulant and antiplatelet drug therapy; (6) Previous cerebral infarction with residual responsible vascular-related severe neurological deficits (mRS ≥3 points); (7) Previous severe myocardial infarction within 2 weeks; (8) Accompanied by other intracranial lesions such as intracranial haemorrhage, aneurysm, arteriovenous malformation, intracranial tumour, etc (9) Non-atherosclerotic stenosis such as arterial entrapment, smoker's disease, active arteritis, and unknown causes; (10) Severe tortuosity or calcification of the target vessel that precludes implantation of a stent or lesion that cannot be dilated; (11) Severe renal impairment, or those who are allergic or resistant to contrast agents, rapamycin (Rapamycin) and its derivatives, cobalt-based alloys, PDLLA; (12) Pregnant or lactating women; (13) Patients participating in other drug or device studies that have not met endpoints

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Bridge	Device: Bridge; Stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of in-stent restenosis at 6 months postoperatively	180±30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	DSA suggesting residual stenosis ≤20% after implantation	post-implantation immediately
Any death or stroke during the follow-up associated with treatment in the target vessel supply region	Number of participants with death or stroke related to treatments for target vessel blood supply area	1 year after stent implantation
Any death or stroke	Number of participants with death or stroke	1 year after stent implantation

Collaborators and Investigators

• Sponsor: MicroPort NeuroTech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Pathological Conditions, Anatomical; Brain Ischemia; Brain Diseases; Thrombosis; Constriction, Pathologic; Vertebrobasilar Insufficiency
• Other Study ID Numbers: Bridge-2023-01-1A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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