Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07352852

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%).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qingdao University Affiliated Hospital

Qingdao, Shandong, China

Location status: Recruiting

Location contact

Yong Zhang

CONTACT

[email protected]

18661818866

Yong Zhang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

    Time frame: 1 year

    mRS≥2

Study contacts

Contact information is provided by the study sponsor or research team.

Yong Zhang

CONTACT

[email protected]

(+86) 18661818866

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Acronym: BRIDGE-INTRA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.