Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial
NCT04948749 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 792
Last updated 2024-12-27
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.
Conditions
- ICAD - Intracranial Atherosclerotic Disease
- ICAS - Intracranial Atherosclerosis
- Drug-eluting Stent
- Stroke
- Drug Eluting Stents (DES)
- Medical Treatment
Interventions
- DEVICE
-
Drug Eluting Stent implantation
The Maurora ® Sirolimus Eluting Stent System for intracranial PTA treatment comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.
- DRUG
-
Aggressive medical treatment
Aggressive medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 6 months after enrollment).
- BEHAVIORAL
-
Risk factor management
Management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
- DRUG
-
Standard medical treatment
Standard medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 3 months after enrollment).
Sponsors & Collaborators
-
Beijing Tiantan Hospital
lead OTHER
Principal Investigators
-
Yongjun Wang, MD · Beijing Tiantan Hospital
-
Zhongrong Miao, MD · Beijing Tiantan Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-02
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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