Clinical trial NCT04948749: Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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)
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 12 months after enrollment
measure: Severe or moderate bleeding (GUSTO score)
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: Residual stenosis after the procedure in DES group
timeFrame: At the end of the procedure
measure: In-stent restenosis (ISR) rate in DES group within 12 months
timeFrame: 12 months after enrollment
measure: Disabling stroke within 1 year
timeFrame: 12 months after enrollment
measure: Any stroke, death or myocardial infarction within 1 year
timeFrame: 12 months after enrollment
measure: Major non-stroke hemorrhage within 1 year
timeFrame: 12 months after enrollment
measure: Modified Rankin Scale score at 1 year
timeFrame: 12 months after enrollment
measure: Death within 1 year
timeFrame: 12 months after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Daxing District People's Hospital
state: Beijing
city: Cangzhou
country: China
facility: Hejian People's Hospital
state: Hebei
city: Tangshan
country: China
facility: North China University of Science and Technology Affiliated Hospital
state: Hebei
city: Xingtai
country: China
facility: Xingtai City Third Hospital
state: Hebei
city: Wuhan
country: China
facility: General Hospital of The Yangtze River Shipping
state: Hubei
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: Inner Mongolia Autonomous Region People's Hospital
state: Inner Mongolia
city: Tongliao
country: China
facility: Tongliao City Hospital
state: Inner Mongolia
city: Wuhai
country: China
facility: Wuhai People's Hospital
state: Inner Mongolia
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Changchun
country: China
facility: The Second Norman Bethune Hospital of JilinUniversity,
state: Jilin
city: Benxi
country: China
facility: General Hospital of Benxi Iron and Steel Co
state: Liaoning
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine
state: Zhejiang
city: Lishui
country: China
facility: Lishui People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Beilun People's Hospital of Ningbo City
state: Zhejiang
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yongjun Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Zhongrong Miao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.