NCT04948749

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 792 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ICAD - Intracranial Atherosclerotic Disease
• ICAS - Intracranial Atherosclerosis
• Drug-eluting Stent
• Stroke
• Drug Eluting Stents (DES)
• Medical Treatment

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-07-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-07-02
• Last updated: 2024-12-27

Locations

18 sites across 1 country: China