NCT04948749Toboroz
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 15.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 358 (tervezett)
- Első benyújtás
- 2021. jún. 16.
- Kezdés
- 2021. júl. 2.
- Elsődleges befejezés
- 2027. dec.
- Fő szponzor
- Beijing Tiantan Hospital
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT04948749
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 358
- 2021. júl. 2. és az elsődleges befejezés (2027. dec.) között
- 18 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Ischemic stroke occurred within 7 days before enrolment
- Cannot tolerate dual antiplatelet therapy
- Major surgery within the past 30 days or planned within 90 days
Más betegség
- Stroke caused by perforating artery occlusion
- 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
- Cannot complete the follow-up due to cognitive, emotional or mental illness
Laborértékek
- Hemoglobin<100g/L, platelet count <100×109/L
- INR>1.5 or there are uncorrectable factors leading to bleeding
Egyéb
- 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
- CT angiographic evidence of severe calcification at target lesion
- Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation
- Contraindications to heparin, rapamycin, contrast and local or general anesthesia
- Severe hepatic and renal dysfunction
- Renal artery, iliac artery, and coronary artery requiring simultaneous intervention
- Life expectancy <1 year
- Pregnant or lactating women
- Other situations that are not suitable for enrolment according to the judgement of the investigator
- Enrolment in another study that would conflict with the current study
Kiket keres a vizsgálat
- 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 [C5-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
Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (18)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Baotou Central Hospital | Baotou | Kína | Toboroz |
| Beijing Tiantan Hospital | Beijing | Kína | Toboroz |
| Beijing Daxing District People's Hospital | Beijing | Kína | Toboroz |
| General Hospital of Benxi Iron and Steel Co | Benxi | Kína | Toboroz |
| Hejian People's Hospital | Cangzhou | Kína | Toboroz |
| The Second Norman Bethune Hospital of JilinUniversity, | Changchun | Kína | Toboroz |
| The First Affiliated Hospital of College of Medicine | Hangzhou | Kína | Toboroz |
| Inner Mongolia Autonomous Region People's Hospital | Hohhot | Kína | Toboroz |
| Lishui People's Hospital | Lishui | Kína | Toboroz |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Kína | Toboroz |
| Beilun People's Hospital of Ningbo City | Ningbo | Kína | Toboroz |
| Shanxi Cardiovascular Hospital | Taiyuan | Kína | Toboroz |
| Shanxi Provincial People's Hospital | Taiyuan | Kína | Toboroz |
| North China University of Science and Technology Affiliated Hospital | Tangshan | Kína | Toboroz |
| Tongliao City Hospital | Tongliao | Kína | Toboroz |
| Wuhai People's Hospital | Wuhai | Kína | Toboroz |
| General Hospital of The Yangtze River Shipping | Wuhan | Kína | Toboroz |
| Xingtai City Third Hospital | Xingtai | Kína | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.