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

Brain Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186024
• Other study ID #: Bridge-2023-01-1A
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: December 2023
• Source: MicroPort NeuroTech Co., Ltd.
• Contact: Huina Lu
• Phone: 15901703529
• Email: HuiNa.Lu[@]microport.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 30, 2025
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Constriction, Pathologic
• Thrombosis
• Vertebral Artery Stenosis
• Vertebrobasilar Insufficiency

Intervention

Device:
• Bridge
Stent implantation

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Affilicated to Captical Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort NeuroTech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of in-stent restenosis at 6 months postoperatively		180±30 days
Secondary	Technical Success	DSA suggesting residual stenosis =20% after implantation	post-implantation immediately
Secondary	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
Secondary	Any death or stroke	Number of participants with death or stroke	1 year after stent implantation