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

NCT06186024 | Unknown

• 1 other identifier: Bridge-2023-01-1A
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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. .

Conditions

Brain Diseases; Vertebral Artery Thrombosis; Vertebral Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Incidence of in-stent restenosis at 6 months postoperatively

  180±30 days

Secondary Outcomes (3)

• Technical Success

  post-implantation immediately

• Any death or stroke during the follow-up associated with treatment in the target vessel supply region

  1 year after stent implantation

• Any death or stroke

  1 year after stent implantation

Study Arms (1)

Experimental group

EXPERIMENTAL

Bridge

Device: Bridge

Interventions

Bridge DEVICE

Stent implantation

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroPort NeuroTech Co., Ltd.: lead

Study Sites (1)

Beijing Tiantan Hospital Affilicated to Captical Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Brain Diseases; Vertebrobasilar Insufficiency

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Huina Lu

CONTACT

15901703529; HuiNa.Lu@microport.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: September 27, 2023
• Primary Completion: July 30, 2024
• Study Completion: January 30, 2025
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

CN (1)