Rapamycin-coated vertebral stents for symptomatic intracranial arterial narrowing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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%.

Why it matters

Who can join: the full rules

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 it's running

• Qingdao University Affiliated Hospital
  Qingdao, Shandong, China Recruiting

Study contacts

• Study coordinator: Yong Zhang
• Email: bravezhang@126.com
• Phone: (+86) 18661818866

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.