A Randomized Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）

Summary

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.

Conditions

• Intracranial Arteriosclerosis

Interventions

DEVICE

Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)

Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)

DEVICE

Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)

Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)

DEVICE

Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China),

Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China)

Sponsors & Collaborators

• MicroPort NeuroTech Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Jianmin Liu · Changhai Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-15

Primary Completion

2027-10-01

Completion

2027-10-01

Countries

• China

Study Locations