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

Launched by MICROPORT NEUROTECH CO., LTD. · Dec 15, 2023

Keywords

ClinConnect Summary

The Bridge-MAX trial is studying a new type of stent used to treat narrowing in the vertebral artery, which can lead to serious brain conditions like strokes. The trial plans to enroll around 36 participants who are between 18 and 80 years old and have already experienced symptoms from their artery narrowing despite medical treatment. To be eligible, participants will need to have a significant degree of narrowing (70% or more) and meet certain health criteria that ensure they can safely undergo the stent procedure.

Participants in this study can expect to have the new stent implanted, followed by routine check-ups at 30 days, 6 months, and 12 months after the procedure to monitor their recovery and any potential complications. The main goals of the trial are to see how well the stent works immediately after implantation and to check for any re-narrowing of the artery over time using follow-up imaging. It's important to know that there are specific health conditions that may exclude someone from participating, such as recent strokes from other causes or significant other health issues.

Gender

ALL

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