Preventing recurrent stroke with drug-eluting stents and aggressive medical treatment

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)

This study is testing whether using special stents along with strong medical treatment can help prevent strokes in patients with certain types of artery disease in the brain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 792 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 18 sites (Beijing, Beijing Municipality and 17 other locations)
• Trial ID: NCT04948749 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of drug-eluting stent (DES) implantation combined with aggressive medical treatment compared to standard medical treatment alone in preventing recurrent strokes in patients with symptomatic intracranial atherosclerotic disease. It is a prospective, multi-center, randomized trial that aims to determine if this combined approach reduces the incidence of strokes or death within one year. The primary endpoints include any stroke or death within 30 days of enrollment or after a revascularization procedure, as well as ischemic strokes occurring in the territory of the qualifying artery beyond 30 days. Participants will be closely monitored for outcomes related to their treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who have experienced an ischemic stroke within the last 30 days due to significant stenosis in a major intracranial artery.

Not a fit: Patients who have had a stroke within the last 7 days or have complex stenosis or occlusions that complicate treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of recurrent strokes in patients with intracranial atherosclerotic disease.

How similar studies have performed: Other studies have shown promise in using drug-eluting stents for similar conditions, but this specific combination approach is relatively novel.

Eligibility criteria

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
11. Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation
12. Cannot tolerate dual antiplatelet therapy
13. Contraindications to heparin, rapamycin, contrast and local or general anesthesia
14. Hemoglobin\<100g/L, platelet count \<100×109/L
15. Severe hepatic and renal dysfunction
16. INR\>1.5 or there are uncorrectable factors leading to bleeding
17. Major surgery within the past 30 days or planned within 90 days
18. Renal artery, iliac artery, and coronary artery requiring simultaneous intervention
19. Life expectancy \<1 year
20. Pregnant or lactating women
21. Cannot complete the follow-up due to cognitive, emotional or mental illness
22. Other situations that are not suitable for enrolment according to the judgement of the investigator
23. Enrolment in another study that would conflict with the current study

Where this trial is running

Beijing, Beijing Municipality and 17 other locations

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Daxing District People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Hejian People's Hospital — Cangzhou, Hebei, China (Recruiting)
• North China University of Science and Technology Affiliated Hospital — Tangshan, Hebei, China (Recruiting)
• Xingtai City Third Hospital — Xingtai, Hebei, China (Recruiting)
• General Hospital of The Yangtze River Shipping — Wuhan, Hubei, China (Recruiting)
• Baotou Central Hospital — Baotou, Inner Mongolia, China (Recruiting)
• Inner Mongolia Autonomous Region People's Hospital — Hohhot, Inner Mongolia, China (Recruiting)
• Tongliao City Hospital — Tongliao, Inner Mongolia, China (Recruiting)
• Wuhai People's Hospital — Wuhai, Inner Mongolia, China (Recruiting)
• The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
• The Second Norman Bethune Hospital of JilinUniversity, — Changchun, Jilin, China (Recruiting)
• General Hospital of Benxi Iron and Steel Co — Benxi, Liaoning, China (Recruiting)
• Shanxi Cardiovascular Hospital — Taiyuan, Shanxi, China (Recruiting)
• Shanxi Provincial People's Hospital — Taiyuan, Shanxi, China (Recruiting)
• The First Affiliated Hospital of College of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Lishui People's Hospital — Lishui, Zhejiang, China (Recruiting)
• Beilun People's Hospital of Ningbo City — Ningbo, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Yongjun Wang, MD — Beijing Tiantan Hospital
• Study coordinator: Ning Ma, MD

Conditions ICAD - Intracranial Atherosclerotic Disease; ICAS - Intracranial Atherosclerosis; Drug-eluting Stent; Stroke; Drug Eluting Stents; Medical Treatment; Drug-eluting stent; Medical treatment