Testing new sizes of stents for treating vertebral artery stenosis

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

This study is testing whether new sizes of stents can effectively treat people with narrowed vertebral arteries and help them feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: MicroPort NeuroTech Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT06186024 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, multicenter, single-arm study enrolling approximately 36 subjects to evaluate the effectiveness of 4.5 mm and 5.0 mm Bridge stents in treating symptomatic vertebral artery stenosis. Participants will undergo stent implantation, and their outcomes will be monitored for immediate success rates and the incidence of in-stent restenosis through DSA imaging at 6 months post-procedure. Follow-up assessments will occur at 30 days, 6 months, and 12 months to evaluate safety and efficacy. The study aims to provide insights into the performance of these new stent sizes in a clinical setting.

Who should consider this trial

Good fit: Ideal candidates are symptomatic vertebral artery stenosis patients aged 18 to 80 who have not responded to medical treatment and have significant stenosis as determined by DSA angiography.

Not a fit: Patients with tandem stenotic lesions or those who have experienced a recent stroke or TIA may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options for patients with vertebral artery stenosis, potentially reducing the risk of stroke and enhancing quality of life.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in using stents for vascular conditions, suggesting potential for success.

Eligibility criteria

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

Where this trial is running

Beijing

• Beijing Tiantan Hospital Affilicated to Captical Medical University — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Huina Lu

Conditions Brain Diseases; Vertebral Artery Thrombosis; Vertebral Artery Stenosis