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.
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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

Feng Gao, Ph.D

13581936066

geofengletter@sina.com

CONTACT

Ming Yang

13331060083

wireyang20@163.com

CONTACT