Rapamycin-coated vertebral stents for symptomatic intracranial arterial narrowing

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

This trial will test whether rapamycin-coated stents placed in narrowed brain arteries can reduce the risk of stroke or death in adults whose symptoms have not improved with medicine.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Qingdao University (Academic / other)
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT07352852 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, single-arm real-world study planning to enroll about 300 adults with symptomatic intracranial atherosclerotic stenosis (≥70% by DSA) who remain symptomatic despite medical therapy. Eligible patients aged 18–80 will receive rapamycin-eluting vertebral stent implantation and be followed before surgery, at implantation, at discharge, and at 1, 6, and 12 months after the procedure. The primary endpoint is any stroke or death within 1 month, with secondary endpoints including immediate implantation success and safety measures such as target-vessel-related stroke or death, all-cause mortality, and 12-month mRS scores. An imaging subgroup of at least 80 participants will undergo 12-month DSA to measure in-stent restenosis >50%.

Who should consider this trial

Good fit: Adults aged 18–80 with symptomatic intracranial atherosclerotic stenosis ≥70% who remain symptomatic despite medical therapy, have anatomy suitable for rapamycin-eluting stent implantation, and can tolerate antiplatelet therapy and informed consent are ideal candidates.

Not a fit: Patients with high baseline disability (mRS ≥3), ischemic stroke within the past 2 weeks, more than two lesions needing treatment, severe organ dysfunction, or allergies/contraindications to rapamycin, contrast, or required antiplatelet drugs are unlikely to benefit.

Why it matters

Potential benefit: If successful, the stent approach could lower the risk of early stroke or death after treatment and reduce the chance the treated artery narrows again by 12 months.

How similar studies have performed: Rapamycin (sirolimus)-eluting stents have reduced restenosis in coronary disease and shown promising but limited and not yet definitive results in intracranial applications, so the approach has partial precedent but is not widely proven for this indication.

Eligibility criteria

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.

Where this trial is running

Qingdao, Shandong

• Qingdao University Affiliated Hospital — Qingdao, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Yong Zhang

Conditions Intracranial Arterial Stenosis; Brain Diseases