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

NCT04948749 | Recruiting DMC

• 1 other identifier: HX-A-018(2021)
• Study Type: interventional
• Target: 792
• Locations: 1 country
• Sites: 18

Brief 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

Keywords

Stroke; Drug-eluting stent; Medical treatment; ICAD-Intracranial Atherosclerotic Disease; ICAS-Intracranial Atherosclerosis; Drug Eluting Stents (DES)

Outcome Measures

Primary Outcomes (2)

• Any stroke or death within 30 days of enrollment or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.

  Primary endpoints are composite event of (1) any stroke or death within 30 days after enrollment, (2) any stroke or death within 30 days after revascularization procedure of the qualifying lesion during follow-up, and (3) ischemic stroke in the territory of the qualifying artery from 31 days to 1 year. Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery. Symptomatic brain hemorrhage is defined as parenchymal, subarachnoid, or intraventricular hemorrhage detected by CT or MRI that is associated with new neurological signs or symptoms (headache, change in level of consciousness, focal neurological symptoms) lasting ≥ 24 hours or a seizure.

  12 months after enrollment

• Severe or moderate bleeding (GUSTO score)

  Bleeding events were defined according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification for severe or life-threatening, moderate, or mild bleeding: Severe or life-threatening- Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate- Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild- Bleeding that does not meet criteria for either severe/life-threatening or moderate bleeding

  12 months after enrollment

Secondary Outcomes (7)

• Residual stenosis after the procedure in DES group

  At the end of the procedure

• In-stent restenosis (ISR) rate in DES group within 12 months

  12 months after enrollment

• Disabling stroke within 1 year

  12 months after enrollment

• Any stroke, death or myocardial infarction within 1 year

  12 months after enrollment

• Major non-stroke hemorrhage within 1 year

  12 months after enrollment

Study Arms (2)

Drug-eluting stent implantation with aggressive medical treatment group

EXPERIMENTAL

DES implantation (The Maurora ® Sirolimus Eluting Stent System) combined with aggressive medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 6 months); management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)

Device: Drug Eluting Stent implantation; Drug: Aggressive medical treatment; Behavioral: Risk factor management

Standard medical treatment group

ACTIVE COMPARATOR

Standard medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 3 months after enrolment), management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)

Behavioral: Risk factor management; Drug: Standard medical treatment

Interventions

Drug Eluting Stent implantation DEVICE

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.

Also known as: Maurora ® Sirolimus Eluting Stent implantation

Drug-eluting stent implantation with aggressive medical treatment group

Aggressive medical treatment DRUG

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).

Also known as: Dual antiplatelet therapy for 6 months

Drug-eluting stent implantation with aggressive medical treatment group

Risk factor management BEHAVIORAL

Management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)

Also known as: Risk factor and life style management

Drug-eluting stent implantation with aggressive medical treatment group; Standard medical treatment group

Standard medical treatment DRUG

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).

Also known as: Dual antiplatelet therapy for 3 months

Standard medical treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 85 years
• 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)
• The diameter of the target vessel between 2.0mm - 4.5mm
• The stenosis lesion length ≤ 14 mm
• Baseline modified Rankin Scale (mRS) score ≤ 3
• Patient understands the purpose and requirements of the study, and has provided informed consent

You may not qualify if:

• Ischemic stroke occurred within 7 days before enrolment
• 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)
• 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)
• Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery
• Stroke caused by perforating artery occlusion
• CT angiographic evidence of severe calcification at target lesion
• Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 6 weeks
• 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
• History of stenting of an intracranial artery
• Presence of any unequivocal cardiac source of embolism
• Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation
• Cannot tolerate dual antiplatelet therapy
• Contraindications to heparin, rapamycin, contrast and local or general anesthesia
• Hemoglobin\<100g/L, platelet count \<100×109/L
• Severe hepatic and renal dysfunction

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (18)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, 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

Related Publications (7)

• Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.

  PMID: 31248666 BACKGROUND

• GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.

  PMID: 30871944 BACKGROUND

• Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.

  PMID: 15800226 BACKGROUND

• Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.

  PMID: 21899409 BACKGROUND

• Shin YS, Kim BM, Suh SH, Jeon P, Kim DJ, Kim DI, Kim BS, Kim KH, Heo JH, Nam HS, Kim YD. Wingspan stenting for intracranial atherosclerotic stenosis: clinical outcomes and risk factors for in-stent restenosis. Neurosurgery. 2013 Apr;72(4):596-604; discussion 604. doi: 10.1227/NEU.0b013e3182846e09.

  PMID: 23277374 BACKGROUND

• Jin M, Fu X, Wei Y, Du B, Xu XT, Jiang WJ. Higher risk of recurrent ischemic events in patients with intracranial in-stent restenosis. Stroke. 2013 Nov;44(11):2990-4. doi: 10.1161/STROKEAHA.113.001824. Epub 2013 Aug 20.

  PMID: 23963335 BACKGROUND

• Lu WD, Huang CW, Li YH, Chen JY. Multiple Mechanisms in 1 In-Stent Restenosis Assessed by Optical Coherence Tomography. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2340-2341. doi: 10.1016/j.jcin.2017.07.017. Epub 2017 Nov 1. No abstract available.

  PMID: 29102578 BACKGROUND

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Stroke

Interventions

Risk Factors

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Yongjun Wang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Zhongrong Miao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Ma, MD

CONTACT

13581889908; maning_03@hotmail.com

Baixue Jia, MD

CONTACT

15010125093; beckyberry@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 2, 2021
• Study Start: July 2, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (18)