Drug- Eluting Stent for Symptomatic Intracranial Arterial Stenosis
Recruiting
Phase 3
Interventional Study
Symptomatic Intracranial Atherosclerotic Stenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 224 (estimated)
- Sponsor
- Beijing Tiantan Hospital · Other
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About This Trial
This investigation is a prospective, multicenter, randomized controlled, non-inferiority clinical trial, to evaluate the safety and efficacy of the investigational device against alternative models/specifications of the control device. The study will be conducted across multiple Chinese centers, with planned enrollment of 224 patients with symptomatic intracranial atherosclerotic stenosis. Subject…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years old and ≤ 80 years old, regardless of gender.
2. Symptomatic intracranial arterial stenosis (TIA/ischemic stroke within 180 days attributed to intracranial arteries including the intracranial internal carotid artery, middle cerebral artery, intracranial vertebr…
Contacts