Status:
NOT_YET_RECRUITING
A Randomized Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）
Lead Sponsor:
MicroPort NeuroTech Co., Ltd.
Conditions:
Intracranial Arteriosclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT06925971
Start Date
April 15 2025
End Date
October 1 2027
Last Update
April 13 2025
Active Locations (1)
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1
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China