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

NCT06925971 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: ALIM-2024-01-CIP-00
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• In-stent restenosis (ISR) rate at 12 months post-procedure

  ISR is defined as \>50% stenosis within or adjacent (within 5 mm) to the stent as well as \>20% absolute luminal loss according to the WASID method diagnosed by DSA

  12 months after surgery(±60days)

Secondary Outcomes (7)

• Technical success rate of stent implantation

  Day 0（within 1hour after procedure）

• Symptomatic ISR rate at 12 months post-procedure

  12 months after surgery(±60days)

• Revascularization rate from qualifying artery at 12 months post-procedure

  During the days of follow-up(up to 12month ±60 days)

• Modified Rankin Scale (mRS) score at 12 months post-procedure

  12 months after surgery(±60days)

• Stroke or death related to qualifying lesion at 30 days, 6 months, and 12 months post-procedure

  During the days of follow-up(up to 12month ±60 days)

Study Arms (5)

Experimental Group A（a self-expanding rapamycin target-eluting stent ）

EXPERIMENTAL

Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group A（total 249 subjects in randomization group in China）

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

Experimental Device B（a balloon-expandable rapamycin target-eluting stent）

EXPERIMENTAL

Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group B（total 249 subjects in randomization group in China）

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

Control group（Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent）

ACTIVE COMPARATOR

Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to control group（total 249 subjects in randomization group in China）

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

Specification subgroup

OTHER

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.

Device: 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)

Overseas subgroup for Experimental Device B in Brazil

OTHER

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

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

Interventions

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

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

Experimental Group A（a self-expanding rapamycin target-eluting stent ）; Specification subgroup

Experimental Device B, a balloon-expandable 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）; Overseas subgroup for Experimental Device B in Brazil; Specification subgroup

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

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

Control group（Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent）

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age 18-80 years old
• \) Symptomatic cerebral artery atherosclerotic stenosis (defined as ischemic stroke or TIA due to qualifying lesion stenosis occurring in the past 6 months) with ineffective antiplatelet therapy or hypoperfusion in the territory of qualifying artery or with poor collateral circulation
• \) Lesion located in a major cerebral artery, including the internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery
• \) 70%-99% stenosis of qualifying lesion according to WASID method diagnosed by DSA
• \) Subject with at least one or more risk factors, including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary artery disease, obesity, smoking history, etc
• \) Subject and/or their legal representatives have the necessary mental capacity to understand the study purpose, agree to participate in the study, and sign the informed consent form

You may not qualify if:

• \) mRS score≥3
• \) Last ischemic stroke onset within 2 weeks
• \) Presence of 2 or more atherosclerotic stenotic lesions in the cerebral arteries requiring interventional or surgical treatment.
• \) Only perforator infarctions in the territory of qualifying artery according to preoperative imaging
• \) Hemorrhagic transformation in the territory of qualifying artery. Any parenchymal, subarachnoid, subdural, or extradural hemorrhage within 30 days prior to procedure, or untreated chronic subdural hematoma(≥5 mm) according to preoperative imaging
• \) Restenosis of qualifying lesion due to previous stenting.
• \) Qualifying lesion with severe calcification, extreme eccentricity, or extreme angulation which may affect stent deployment
• \) Stenosis caused by non-atherosclerotic lesions, such as arterial dissection, moya-moya disease, or vasculitis
• \) Concomitant severe stenosis (≥70% stenosis as measured by the WASID method) in the distal or proximal to qualifying lesion
• \) Concomitant multiple stenoses where qualifying lesions cannot be identified
• \) Thrombus in the qualifying artery or complete occlusion of the qualifying artery
• \) Severe calcification or tortuosity of qualifying artery to prevent stent from successful positioning and dilatation
• \) Stenting in qualifying artery within one year
• \) Concomitant aneurysms requiring treatment
• \) Concomitant intracranial malignant tumors, intracranial arteriovenous malformations, intracranial venous sinus thrombosis, or other conditions inappropriate to participate in the study

Sponsors & Collaborators

• MicroPort NeuroTech Co., Ltd.: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianmin Liu

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huina Lu

CONTACT

+8615901703529; HuiNa.Lu@microport.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 13, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)