Intracranial Arterial StenosisBRIDGE-INTRANCT07352852
Rapamycin-Eluting Vertebral Stents In The Real-World Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
An observational study of Intracranial Arterial Stenosis and Brain Diseases, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Arterial Stenosis, Brain Diseases
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects undergoing rapamycin-eluting stent implantation
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qingdao University Affiliated Hospital
Qingdao, Shandong
Yong Zhang, 18661818866, bravezhang@126.com
Yong Zhang
About this study
Official title: 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%).
- Conditions
- Intracranial Arterial Stenosis, Brain Diseases
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| exposed group | subjects undergoing rapamycin-eluting stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any stroke or death within 1 month after the procedure
Measured: 1 month
Secondary outcomes (6)
Incidence of in-stent restenosis (stenosis degree >50%) at 1year (imaging subgroup)
Measured: 1 year
Immediate techenical success rate of stent implantation (imaging subgroup)
Measured: immediately after the intervention
Incidence of stroke or neurogenic death within 1-year follow-up
Measured: 1 year
Incidence of target vessel-related stroke or death within 1-year follow-up
Measured: 1 year
All-cause mortality within 1-year follow-up
Measured: 1 year
mRS score at 1-year follow-up
mRS≥2
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start14 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Arterial StenosisStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhangyong, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352852
- Sponsor's protocol ID
- Bridge-2024-04-CIP-01
- Acronym
- BRIDGE-INTRA
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapamycin-eluting Vertebral Stents in the Real-world Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
- ClinicalTrials.gov ID
- NCT07352852
- Acronym / sponsor ID
- BRIDGE-INTRA / Bridge-2024-04-CIP-01
- Conditions
- Intracranial Arterial Stenosis, Brain Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exposed group | – | –subjects undergoing rapamycin-eluting stent implantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects undergoing rapamycin-eluting stent implantation
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of any stroke or death within 1 month after the procedure
Time frame: 1 month
6 secondary outcomes
Incidence of in-stent restenosis (stenosis degree >50%) at 1year (imaging subgroup)
Time frame: 1 year
Immediate techenical success rate of stent implantation (imaging subgroup)
Time frame: immediately after the intervention
Incidence of stroke or neurogenic death within 1-year follow-up
Time frame: 1 year
Incidence of target vessel-related stroke or death within 1-year follow-up
Time frame: 1 year
All-cause mortality within 1-year follow-up
Time frame: 1 year
mRS score at 1-year follow-up
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Arterial Stenosis and Brain Diseases, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Zhang ((+86) 18661818866, bravezhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any stroke or death within 1 month after the procedure (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.