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

A Prospective, Multi-center, Open-label, Controlled, Superiority, Randomized, Controlled Registration Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Arteriosclerosis
• Intervention / Treatment: 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); Device: Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China),

• Study Type: Interventional
• Enrollment (Estimated): 279
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Huina Lu; Phone Number: +8615901703529; Email: HuiNa.Lu@microport.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Changhai Hospital
      • Contact: Jianmin Liu, Ph.D; Email: liu118@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1) Age 18-80 years old
• 2) 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
• 3) Lesion located in a major cerebral artery, including the internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery
• 4) 70%-99% stenosis of qualifying lesion according to WASID method diagnosed by DSA
• 5) Subject with at least one or more risk factors, including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary artery disease, obesity, smoking history, etc
• 6) 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

Exclusion Criteria:

• 1) mRS score≥3
• 2) Last ischemic stroke onset within 2 weeks
• 3) Presence of 2 or more atherosclerotic stenotic lesions in the cerebral arteries requiring interventional or surgical treatment.
• 4) Only perforator infarctions in the territory of qualifying artery according to preoperative imaging
• 5) 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
• 6) Restenosis of qualifying lesion due to previous stenting.
• 7) Qualifying lesion with severe calcification, extreme eccentricity, or extreme angulation which may affect stent deployment
• 8) Stenosis caused by non-atherosclerotic lesions, such as arterial dissection, moya-moya disease, or vasculitis
• 9) Concomitant severe stenosis (≥70% stenosis as measured by the WASID method) in the distal or proximal to qualifying lesion
• 10) Concomitant multiple stenoses where qualifying lesions cannot be identified
• 11) Thrombus in the qualifying artery or complete occlusion of the qualifying artery
• 12) Severe calcification or tortuosity of qualifying artery to prevent stent from successful positioning and dilatation
• 13) Stenting in qualifying artery within one year
• 14) Concomitant aneurysms requiring treatment
• 15) Concomitant intracranial malignant tumors, intracranial arteriovenous malformations, intracranial venous sinus thrombosis, or other conditions inappropriate to participate in the study
• 16) Resistant hypertension (systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg) despite use of medication
• 17) Acute myocardial infarction within 4 weeks prior to enrollment, or suspected cardiogenic embolism
• 18) Subjects with severe systemic diseases that cannot tolerate surgery, such as severe hepatic or renal impairment
• 19) Severe cognitive impairment or mental diseases
• 20) Contraindications to anticoagulants or antiplatelet drugs, such as anticoagulant or antiplatelet drug allergy, active bleeding, or coagulation disorder
• 21) Subjects with allergy or suspected allergy to anesthetics, contrast agents, rapamycin, polylactic acid, nickel-titanium alloy, cobalt-chromium alloy, stainless steel, and other stent materials, medications, and intraoperative medications
• 22) Women who are pregnant or breastfeeding
• 23) Subjects who are participating or planning to participate in any drug or device clinical study at the time of enrollment
• 24) Life expectancy ≤ 1 year
• 25) Other conditions inapplicable to participate in the study according to investigators' judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group A（a self-expanding rapamycin target-eluting stent ）; 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 A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Experimental: Experimental Device B（a balloon-expandable rapamycin target-eluting stent）; 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); Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Active Comparator: Control group（Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent）; 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),; Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China)
Other: Specification subgroup; 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); 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)
Other: Overseas subgroup for Experimental Device B in Brazil; 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); Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate of stent implantation	defined as successful implantation into qualifying lesion as well as successful retraction of delivery system	Day 0（within 1hour after procedure）
Symptomatic ISR rate at 12 months post-procedure	ISR (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) occurs with ischemic stroke or TIA from target lesion restenosis. Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction. TIA is defined as transient focal neurological dysfunction from brain/spinal cord/retinal ischemia, with symptoms lasting<24 hours and no acute infarction.	12 months after surgery(±60days)
Revascularization rate from qualifying artery at 12 months post-procedure	During follow-up, revascularization procedures (including interventional thrombectomy, angioplasty, vascular bypass, etc.) due to ischemic stroke or TIA from target lesions. Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction. TIA is defined as transient focal neurological dysfunction from brain/spinal cord/retinal ischemia, with symptoms lasting<24 hours and no acute infarction.	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	Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction.	During the days of follow-up(up to 12month ±60 days)
Any stroke or death at 30 days, 6 months, and 12 months post-procedure	Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction.	During the days of follow-up(up to 12month ±60 days)
Study device related serious adverse event rate during follow-up		During the days of follow-up(up to 12month ±60 days)

Collaborators and Investigators

• Sponsor: MicroPort NeuroTech Co., Ltd.
• Investigators: Principal Investigator: Jianmin Liu, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Intracranial Arteriosclerosis; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; MTOR Inhibitors; Sirolimus; Temsirolimus
• Other Study ID Numbers: ALIM-2024-01-CIP-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No