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NCT06925971
A Randomized Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）
Phase 3 trial testing Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) in Intracranial Arteriosclerosis in 279 participants. Not yet recruiting.
1 October 2027
Quick facts
| Lead sponsor | MicroPort NeuroTech Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 279 |
| Start date | 15 April 2025 |
| Primary completion | 1 October 2027 |
| Estimated completion | 1 October 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
- Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
- Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China),
Conditions studied
- Intracranial Arteriosclerosis — all drugs for Intracranial Arteriosclerosis →
Sponsor
MicroPort NeuroTech Co., Ltd.
Who can join
Adults 18 to 80, any sex, with Intracranial Arteriosclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The trial is a prospective, multicenter, open-label, superiority, randomized controlled clinical trial. The experimental groups include two types of drug-eluting stents: * Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) * Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) The device used in the control group is the Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China), According to the inclusion and exclusion criteria specified in the protocol, approximately 249 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group A, Experimental Group B, or the control group. Considering the broader applicability of Experimental Device A and Experimental Device B compared to the control device, a specification subgroup is established. 20 subjects with lesions only suitable for the unique specifications of Experimental Device A or Experimental Device B will be enrolled in China. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing. Moreover, a subgroup of Experimental Device B is established at a study center in Brazil. 10 subjects meeting the trial's inclusion and criteria will be enrolled. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing, only to support overseas registration. Overall, the total sample size for the study is 279 subjects. Clinical assessment will be conducted for all subjects before the procedure, during the procedure, at discharge, at 1 month (±7 days) follow-up, at 6 months (±30 days) follow-up, and at 12 months (±60 days) follow-up. At 12 months (±60 days), patients will undergo follow-up with DSA imaging. Unscheduled follow-ups may be performed as needed to record relevant indicators and evaluate the safety and efficacy of the two drug-eluting stents in the treatment of symptomatic cerebral artery atherosclerotic stenosis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06925971
- Europe PMC full search
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Related trials
Other recruiting trials for Intracranial Arteriosclerosis
Currently open trials in the same condition.
- NCT05692882 — A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China · NA · recruiting
- NCT05047172 — Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis · Phase 3 · active not recruiting
Other MicroPort NeuroTech Co., Ltd. trials
Trials by the same sponsor.
- NCT06843616 — A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA（FAST-HET） · NA · recruiting
- NCT07314047 — The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation · NA · recruiting
- NCT06683118 — Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis · NA · enrolling by invitation
- NCT06466564 — Bioabsorbable/Nufairy Coil Application Trial in China · NA · active not recruiting
- NCT06989931 — Intracranial Distal Access Catheter in Neurointerventional Therapy · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06925971 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MicroPort NeuroTech Co., Ltd.
- Last refreshed: 13 April 2025
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