Rapamycin-Eluting Vertebral Stents In The Real-World Treatment of Symptomatic Intracranial Atherosclerotic Stenosis (BRIDGE-INTRA)

Rapamycin-eluting Vertebral Stents in the Real-world Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

This clinical trial is a prospective, multicenter, single-arm study. About 300 subjects undergoing rapamycin-eluting stent implantation will be enrolled based on the inclusion and exclusion criteria. The primary endpoint is the rate of any stroke or death within 1 month. Secondary efficacy endpoints include immediate stent implantation success. Safety endpoints cover the incidence of stroke or neurological death, target-vessel-related stroke or death, all-cause mortality, and mRS scores at 12-month follow-ups. Subjects will be clinically followed up before surgery, device implantation, discharge, and at 1, 6, and 12 months post-surgery. An imaging subgroup of at least 80 subjects who agree to DSA follow-up at 12 months will assess in-stent restenosis (>50%).

Study Overview

• Status: Recruiting
• Conditions: Brain Diseases; Intracranial Arterial Stenosis

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Yong Zhang; Phone Number: (+86) 18661818866; Email: bravezhang@126.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China
      • Recruiting
      • Qingdao University Affiliated Hospital
      • Principal Investigator: Yong Zhang
      • Contact: Yong Zhang; Phone Number: 18661818866; Email: bravezhang@126.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

subjects undergoing rapamycin-eluting stent implantation

Description

Inclusion Criteria:

• Age ≥18 and ≤80 years;
• Symptomatic intracranial atherosclerotic stenosis patients with ineffective medical treatment;
• Digital subtraction angiography (DSA) shows target lesion stenosis ≥70%;
• Suitable for implantation of rapamycin-targeted drug-eluting stents;
• The patient and/or their authorized representative can understand the study purpose, agree to participate, and sign the informed consent form.

Exclusion Criteria:

• Modified Rankin Scale (mRS) score ≥3;
• Ischemic stroke within the past 2 weeks;
• Presence of more than 2 intracranial atherosclerotic stenosis lesions requiring interventional treatment;
• Severe contraindications to heparin, aspirin, ticagrelor, clopidogrel, or other antiplatelet drugs, and inability to tolerate anticoagulant/antiplatelet therapy;
• Severe dysfunction of major organs (e.g., severe hepatic insufficiency, renal insufficiency, heart failure);
• Severe allergies to contrast agents, rapamycin and its derivatives, cobalt-based alloys, or polylactic acid;
• Pregnant or lactating women;
• Participation in other drug or device studies without reaching the endpoint;
• Life expectancy less than 12 months;
• Lesions or vascular access deemed unsuitable for rapamycin drug-eluting stent implantation by the operator.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
exposed group; subjects undergoing rapamycin-eluting stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of any stroke or death within 1 month after the procedure	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of in-stent restenosis (stenosis degree >50%) at 1year (imaging subgroup)		1 year
Immediate techenical success rate of stent implantation (imaging subgroup)		immediately after the intervention
Incidence of stroke or neurogenic death within 1-year follow-up		1 year
Incidence of target vessel-related stroke or death within 1-year follow-up		1 year
All-cause mortality within 1-year follow-up		1 year
mRS score at 1-year follow-up	mRS≥2	1 year

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Brain Diseases
• Other Study ID Numbers: Bridge-2024-04-CIP-01

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