Loading clinical trials...

Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial | Clinical Trials | Clareo Health

RECRUITINGNA

Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial

Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial: a Prospective, Randomized, Open-labelled, Blinded End-point Trial (DREAM-PRIDE)

NCT04948749•Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

The aim of DREAM-PRIDE is to evaluate whether implantation of drug-eluting stent (DES) combined with aggressive medical treatment is more efficacious in prevention of 1-year stroke recurrence than standard medical treatment alone for symptomatic intracranial atherosclerotic disease.

Detailed Description

This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent combined with aggressive medical treatment versus standard medical treatment to treat symptomatic intracranial atherosclerotic disease. Primary efficacy endpoints (any of the following): 1) any stroke or death within 30 days after enrollment, 2) any stroke or death within 30 days after a revascularization procedure of the qualifying lesion during follow-up, 3) ischemic stroke in the territory of the qualifying artery beyond 30 days to 1 year.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age from 18 to 85 years
•2. Patients with ischemic stroke within 30 days of enrolment attributed to 70% to 99% stenosis of a major intracranial artery (internal carotid artery \[C4-C7\], middle cerebral artery \[M1\], vertebral artery \[V4\], or basilar artery) on CTA (According to WASID method)
•3. The diameter of the target vessel between 2.0mm - 4.5mm
•4. The stenosis lesion length ≤ 14 mm
•5. Baseline modified Rankin Scale (mRS) score ≤ 3
•6. Patient understands the purpose and requirements of the study, and has provided informed consent

Exclusion Criteria

•1. Ischemic stroke occurred within 7 days before enrolment
•2. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception is allowed if stenosis or occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery)
•3. Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (NOTE: an exception is that if bilateral vertebral arteries with 70%-99% stenosis but unequal in size, the dominant side is considered as symptomatic)
•4. Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery
•5. Stroke caused by perforating artery occlusion
•6. CT angiographic evidence of severe calcification at target lesion
•7. Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 6 weeks
•8. Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, Moyamoya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc
•9. History of stenting of an intracranial artery
•10. Presence of any unequivocal cardiac source of embolism
+13 more criteria

Locations (18)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Beijing Daxing District People's Hospital

Beijing, Beijing Municipality, China

Hejian People's Hospital

Cangzhou, Hebei, China

North China University of Science and Technology Affiliated Hospital

Tangshan, Hebei, China

Xingtai City Third Hospital

Xingtai, Hebei, China

General Hospital of The Yangtze River Shipping

Wuhan, Hubei, China

Baotou Central Hospital

Baotou, Inner Mongolia, China

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China

Tongliao City Hospital

Tongliao, Inner Mongolia, China

Wuhai People's Hospital

Wuhai, Inner Mongolia, China

Key Dates

Start Date

July 2, 2021

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

December 27, 2024

Enrollment

792

ESTIMATED participants

Conditions

ICAD - Intracranial Atherosclerotic DiseaseICAS - Intracranial AtherosclerosisDrug-eluting StentStrokeDrug Eluting Stents (DES)Medical Treatment

Interventions

Drug Eluting Stent implantation

DEVICE

Aggressive medical treatment

DRUG

Risk factor management

BEHAVIORAL

Standard medical treatment

DRUG

Contacts

Ning Ma, MD

CONTACT

13581889908 maning_03@hotmail.com

Baixue Jia, MD

CONTACT

15010125093 beckyberry@163.com

IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)

NCT05974033

ICAS - Intracranial Atherosclerosis

View study

UNKNOWNNA

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions

NCT04744571

Coronary Artery DiseaseCoronary Occlusion+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial

Inclusion Criteria

Exclusion Criteria

IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions

In-stent Repair and Vessel Reaction of STEMI Patients With OCT

Independent OCT Registry on Very Late Bioresorbable Scaffold Thrombosis

Proper Fractional Flow Reserve Criteria for Intermediate Lesions in the Era of Drug-eluting Stent