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

Last updated: April 11, 2025
Sponsor: MicroPort NeuroTech Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hypercholesterolemia

Coronary Artery Disease

Cardiovascular Disease

Treatment

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

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

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

Clinical Study ID

NCT06925971
ALIM-2024-01-CIP-00
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-80 years old
  1. Symptomatic cerebral artery atherosclerotic stenosis (defined as ischemicstroke or TIA due to qualifying lesion stenosis occurring in the past 6 months)with ineffective antiplatelet therapy or hypoperfusion in the territory ofqualifying artery or with poor collateral circulation
  1. Lesion located in a major cerebral artery, including the internal carotidartery, middle cerebral artery, vertebral artery, or basilar artery
  1. 70%-99% stenosis of qualifying lesion according to WASID method diagnosed byDSA
  1. Subject with at least one or more risk factors, including hypertension,diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary arterydisease, obesity, smoking history, etc
  1. Subject and/or their legal representatives have the necessary mental capacityto understand the study purpose, agree to participate in the study, and signthe informed consent form

Exclusion

Exclusion Criteria:

  1. mRS score≥3
  1. Last ischemic stroke onset within 2 weeks
  1. Presence of 2 or more atherosclerotic stenotic lesions in the cerebral arteriesrequiring interventional or surgical treatment.
  1. Only perforator infarctions in the territory of qualifying artery according topreoperative imaging
  1. Hemorrhagic transformation in the territory of qualifying artery. Anyparenchymal, subarachnoid, subdural, or extradural hemorrhage within 30 daysprior to procedure, or untreated chronic subdural hematoma(≥5 mm) according topreoperative imaging
  1. Restenosis of qualifying lesion due to previous stenting.
  1. Qualifying lesion with severe calcification, extreme eccentricity, or extremeangulation which may affect stent deployment
  1. Stenosis caused by non-atherosclerotic lesions, such as arterial dissection,moya-moya disease, or vasculitis
  1. Concomitant severe stenosis (≥70% stenosis as measured by the WASID method) inthe distal or proximal to qualifying lesion
  1. Concomitant multiple stenoses where qualifying lesions cannot be identified
  1. Thrombus in the qualifying artery or complete occlusion of the qualifyingartery
  1. Severe calcification or tortuosity of qualifying artery to prevent stent fromsuccessful positioning and dilatation
  1. Stenting in qualifying artery within one year
  1. Concomitant aneurysms requiring treatment
  1. Concomitant intracranial malignant tumors, intracranial arteriovenousmalformations, intracranial venous sinus thrombosis, or other conditionsinappropriate to participate in the study
  1. Resistant hypertension (systolic pressure ≥180 mmHg or diastolic pressure ≥110mmHg) despite use of medication
  1. Acute myocardial infarction within 4 weeks prior to enrollment, or suspectedcardiogenic embolism
  1. Subjects with severe systemic diseases that cannot tolerate surgery, such assevere hepatic or renal impairment
  1. Severe cognitive impairment or mental diseases
  1. Contraindications to anticoagulants or antiplatelet drugs, such asanticoagulant or antiplatelet drug allergy, active bleeding, or coagulationdisorder
  1. 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 intraoperativemedications
  1. Women who are pregnant or breastfeeding
  1. Subjects who are participating or planning to participate in any drug or deviceclinical study at the time of enrollment
  1. Life expectancy ≤ 1 year
  1. Other conditions inapplicable to participate in the study according toinvestigators' judgment

Study Design

Total Participants: 279
Treatment Group(s): 3
Primary Treatment: Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Phase: 3
Study Start date:
April 15, 2025
Estimated Completion Date:
October 01, 2027

Connect with a study center

  • Shanghai Changhai Hospital

    Shanghai, Shanghai
    China

    Site Not Available

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