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RecruitingNCT07352852BRIDGE-INTRAUpdated Jan 20, 2026

Rapamycin-Eluting Vertebral Stents In The Real-World Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

An observational study in Intracranial Arterial Stenosis and Brain Diseases, sponsored by The Affiliated Hospital of Qingdao University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by The Affiliated Hospital of Qingdao University · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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%).

02

Conditions studied

  • Intracranial Arterial Stenosis
  • Brain Diseases

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03

In context

Brain Diseases

758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 265 observational studies indexed under Brain Diseases.

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Lead sponsor

The Affiliated Hospital of Qingdao University is the lead sponsor of 142 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

subjects undergoing rapamycin-eluting stent implantation

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • exposed group

    subjects undergoing rapamycin-eluting stent implantation

06

What researchers measure

Primary outcomes

  1. Incidence of any stroke or death within 1 month after the procedure

    Time frame: 1 month

Secondary outcomes

  1. Incidence of in-stent restenosis (stenosis degree >50%) at 1year (imaging subgroup)

    Time frame: 1 year

  2. Immediate techenical success rate of stent implantation (imaging subgroup)

    Time frame: immediately after the intervention

  3. Incidence of stroke or neurogenic death within 1-year follow-up

    Time frame: 1 year

  4. Incidence of target vessel-related stroke or death within 1-year follow-up

    Time frame: 1 year

  5. All-cause mortality within 1-year follow-up

    Time frame: 1 year

  6. mRS score at 1-year follow-up

    mRS≥2

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Qingdao University Affiliated Hospital
    Qingdao, Shandong, China
    • Yong Zhang · Contact · bravezhang@126.com · 18661818866
    • Yong Zhang · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07352852
Lead sponsor
The Affiliated Hospital of Qingdao University
Responsible party
zhangyong (Chief Physician, Department of Neurointerventional Medicine, The Affiliated Hospital of Qingdao University, The Affiliated Hospital of Qingdao University) — Principal investigator
First posted
Jan 20, 2026
Start date
May 14, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jan 20, 2026

Study contacts

Yong Zhang
Contact
bravezhang@126.com
(+86) 18661818866

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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