Drug-Coated Balloon vs Aggressive Medical Management for High-Risk Symptomatic Intracranial Atherosclerotic Stenosis (DRBEYOND2)
Drug-coated Balloon for Endovascular Treatment Versus Aggressive Medical Management in High-Risk Symptomatic Intracranial Atherosclerotic Stenosis
DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint, parallel-group clinical trial designed to evaluate the efficacy and safety of drug-coated balloon (DCB) angioplasty plus aggressive medical management compared with aggressive medical management alone in patients with high-risk symptomatic intracranial atherosclerotic stenosis (sICAS).
A total of 570 eligible patients will be randomized in a 1:1 ratio to the DCB group or the medical management group. Patients assigned to the DCB group will undergo DCB angioplasty in addition to aggressive medical management, with rescue stenting permitted when clinically necessary according to the study protocol. Patients assigned to the control group will receive aggressive medical management alone.
The primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Participants will be followed for up to 3 years to further evaluate recurrent ischemic events, vascular outcomes, functional outcomes, and long-term safety.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Symptomatic intracranial atherosclerotic stenosis (sICAS) is an important cause of ischemic stroke and recurrent cerebrovascular events. Although aggressive medical management is the standard treatment, patients with severe stenosis and high-risk clinical or hemodynamic features may remain at substantial risk of recurrent ischemic events. Previous randomized trials of intracranial stenting have raised concerns regarding periprocedural safety, whereas balloon angioplasty has shown potential benefit but may be limited by arterial dissection, elastic recoil, and restenosis. Drug-coated balloon angioplasty may provide an alternative endovascular strategy by combining luminal enlargement with local delivery of an antiproliferative agent while minimizing permanent intracranial implants.
DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label trial with blinded endpoint assessment. The study will enroll 570 patients with high-risk symptomatic intracranial atherosclerotic stenosis involving a major intracranial artery. Eligible patients must have had a recent ischemic stroke or transient ischemic attack attributable to the qualifying artery, severe intracranial stenosis, and prior treatment with at least one antithrombotic agent and/or guideline-based vascular risk-factor management. For anterior-circulation lesions, evidence of hemodynamic compromise is additionally required according to the protocol.
Participants will be randomly assigned in a 1:1 ratio to DCB angioplasty plus aggressive medical management or aggressive medical management alone. In the intervention group, DCB angioplasty will be performed using a submaximal angioplasty strategy. Rescue stenting may be used in cases of severe dissection, significant residual stenosis, or marked elastic recoil according to predefined procedural criteria.
Both treatment groups will receive standardized aggressive medical management, including antiplatelet therapy, lipid-lowering therapy, blood-pressure control, diabetes management, and management of other vascular risk factors. The medical regimen and risk-factor targets will be applied consistently across both treatment groups.
The primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Secondary outcomes include recurrent ischemic stroke or transient ischemic attack, target-vessel revascularization, hemorrhagic events, mortality, functional outcome, quality of life, and target-vessel restenosis. Exploratory outcomes include high-resolution magnetic resonance imaging changes of the target vessel and clinical and vascular outcomes through 3 years.
Participants will undergo scheduled follow-up at 7 days, 30 days, 3 months, 6 months, and 12 months, followed by assessments every 6 months through 3 years. The trial is designed to determine whether DCB-based endovascular treatment in addition to aggressive medical management can reduce recurrent cerebrovascular events while maintaining acceptable procedural safety in patients with high-risk sICAS.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dapeng Mo, MD
- Telefonní číslo: 18811039300
- E-mail: bjttmodp@163.com
Studijní záloha kontaktů
- Jméno: Changchun Jiang, MD
- Telefonní číslo: 13347180510
- E-mail: 15848246828@163.com
Studijní místa
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Čína, 100010
- Beijing Tiantan Hospital
-
-
Inner Mongolia
-
Baotou, Inner Mongolia, Čína, 014000
- Baotou Central Hospital
-
Kontakt:
- Changchun Jiang, MD
- Telefonní číslo: +8613347180510
- E-mail: 15848246828@163.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age 18-80 years old, regardless of gender
- Patients with symptomatic ICAS caused by stenosis of a major intracranial artery (the degree of ischemic stroke with target vessel stenosis within 90 days before enrollment is required to be 70-99%, or the degree of transient ischemic attack with target vessel stenosis is required to be 80-99%), standardized drug management of at least one antithrombotic drug and/or vascular risk factors
- DSA or CTA confirmed that the stenosis degree of one main intracranial artery (internal carotid artery C4-C7 segment, middle cerebral artery M1 segment, vertebral artery V4 segment and basilar artery) was between 70% and 99% (measured by WASID method), and was corresponding to the clinical symptoms. The normal diameter of the proximal end of the target lesion was ≥ 2mm, and the length of the target lesion was ≤ 15mm
- If the target lesion is located in the anterior circulation system (C4-C7 of the internal carotid artery or M1 of the middle cerebral artery), it is required that there is hypoperfusion in the blood supply area of the target vessel (at least one of the following conditions is met): ①head CTP or PWI showed that CBF in the target vessel area decreased significantly (the lesion side decreased by more than 30% compared with the opposite side); ②Cerebral infarction with hemodynamic abnormalities confirmed by head CT or MRI (such as watershed infarction); ③ASITN/SIR collateral circulation score based on DSA<3 points)
- Those who voluntarily participated in the study and signed the informed consent
Exclusion Criteria:
- Serious calcification of target vessels, or serious distortion of target vessels or anatomical factors make it difficult for interventional instruments to be in place
- Severe stenosis or occlusion of extracranial or intracranial vessels in series at the proximal or distal end of the target vessel
- Major surgical operations have been performed in recent 3 weeks
- Cerebral hemorrhage, massive cerebral infarction (the infarct area is greater than 50% of the middle cerebral artery supply area; cerebellar infarction: the infarct diameter is greater than 3cm) and myocardial infarction have occurred in the past three months
- The target lesion has undergone stent implantation before
- Intracranial artery stenosis caused by non atherosclerotic lesions, including but not limited to: arterial dissection, moyamoya disease, vasculitis, radiation vascular disease or fibromuscular dysplasia
- mRS score ≥ 3
- Patients with coagulation dysfunction
- Those who cannot tolerate anesthesia and anticoagulant drugs, are contraindicated or allergic to surgical drugs (paclitaxel, heparin, contrast agent, aspirin, clopidogrel, etc.), and are allergic to surgical instruments or operating devices
- Platelet (PLT<90×109/L),hematocrit (<30%), international normalized ratio (INR)>1.5, uncontrollable severe hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg),severe liver injury (ALT or AST more than 3 times the normal value), severe renal function injury (creatinine>3mg/dl,>265μmol/L),and severe insufficiency of other important organs such as heart and lung
- The subjects participated in other clinical trials and have not completed the follow-up or the researchers judged that the patients' compliance was poor and they were unable to complete the follow-up as required
- Pregnant or lactating women, or those who plan to become pregnant within one year
- The disease will cause difficulties in treatment and follow-up evaluation (such as dementia or mental disorders, cancer, infection, severe metabolic diseases), and it is speculated that the life expectancy of the participants is less than 3 years
- Other cases that clinicians think should be excluded
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Drug-Coated Balloon Angioplasty Plus Aggressive Medical Management
Participants assigned to this group will undergo drug-coated balloon angioplasty in addition to aggressive medical management. Rescue stenting is permitted when clinically necessary according to predefined procedural criteria, including severe dissection, significant residual stenosis, or marked elastic recoil. |
Participants randomized to the experimental group will undergo intracranial drug-coated balloon angioplasty using a submaximal angioplasty strategy. Predilation with an uncoated balloon is performed before drug-coated balloon angioplasty. Rescue stenting is permitted when severe dissection, residual stenosis >50%, marked elastic recoil, or other protocol-defined conditions occur. |
|
Aktivní komparátor: Aggressive Medical Management Alone
Participants assigned to this group will receive aggressive medical management alone, including standardized antiplatelet therapy and intensive management of vascular risk factors. |
Aggressive medical management will be provided to participants in both groups and includes antiplatelet therapy, intensive lipid-lowering treatment, blood pressure and glucose control, and management of other vascular risk factors. Aspirin 100 mg/day is administered throughout follow-up, with clopidogrel 75 mg/day during the first 90 days after enrollment. Alternative antiplatelet therapy may be used according to platelet function or CYP2C19 genotype when appropriate. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment
Časové okno: within 30 days after enrollment;within 30 days to 1 year after enrollment
|
Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment. |
within 30 days after enrollment;within 30 days to 1 year after enrollment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants With Any stroke or death within 30 days after enrollment
Časové okno: Within 30 days after enrollment
|
Percentage of Participants With Any stroke or death within 30 days after enrollment. |
Within 30 days after enrollment
|
|
Percentage of Participants With Recurrent Ischemic Stroke in any region within 30 days to 1 year after enrollment
Časové okno: Within 30 days to 1 year after enrollment
|
Recurrence of ischemic stroke in any region within 30 days to 1 year after enrollment. |
Within 30 days to 1 year after enrollment
|
|
Percentage of Participants With Recurrent TIA in the Territory of the Qualifying Artery Within 1 Year After Enrollment
Časové okno: Within 1 year after enrollment
|
TIA recurrence in target vessel area within 1 year after enrollment. |
Within 1 year after enrollment
|
|
Percentage of Participants With Recurrent TIA in Any Vascular Territory Within 1 Year After Enrollment
Časové okno: Within 1 year after enrollment
|
TIA recurrence in any region within 1 year after enrollment. |
Within 1 year after enrollment
|
|
Percentage of Participants Undergoing Target-Vessel Revascularization Within 1 Year After Enrollment
Časové okno: Within 1 year after enrollment
|
Salvage revascularization of target vessels within 1 year after enrollment (mechanical thrombectomy/arterial thrombolysis/angioplasty/vascular bypass). |
Within 1 year after enrollment
|
|
Percentage of Participants With Coronary Ischemic Events Within 1 Year After Enrollment
Časové okno: Within 1 year after enrollment
|
Coronary ischemic events within 1 year after enrollment (including myocardial infarction or angina pectoris). |
Within 1 year after enrollment
|
|
Modified Rankin Scale (mRS) Score at 1 Year (±1 Month) After Enrollment
Časové okno: 1 year (± 1 month) after enrollment
|
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death. |
1 year (± 1 month) after enrollment
|
|
EQ-5D Score at 1 Year (±1 Month) After Enrollment
Časové okno: 1 year (± 1 month) after enrollment
|
The change in functional health status and quality of life measured by EuroQol five dimensions questionnaire (EQ-5D) at 1 year (± 1 month) after enrollment. |
1 year (± 1 month) after enrollment
|
|
Percentage of Participants With Target-Vessel Restenosis at 1 Year (±1 Month) After Enrollment in the Experimental Group
Časové okno: 1 year (±1 month) after enrollment
|
Target vessel restenosis at 1 year (±1 month) after enrollment (experimental group only, evaluated by CTA). |
1 year (±1 month) after enrollment
|
|
Percentage of Participants With Symptomatic Target-Vessel Restenosis at 1 Year (±1 Month) After Enrollment in the Experimental Group
Časové okno: 1 year (±1 month) after enrollment
|
Symptomatic restenosis of target vessels at 1 year (± 1 month) after enrollment (evaluation of the experimental group only). |
1 year (±1 month) after enrollment
|
|
Percentage of Participants With Hemorrhagic Stroke Within 1 Year After Enrollment
Časové okno: Within 1 year after enrollment
|
Hemorrhagic stroke within 1 year after enrollment (cerebral hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc.). |
Within 1 year after enrollment
|
|
Percentage of Participants With Extracranial Hemorrhage Within 1 Year After Enrollment
Časové okno: Within 1 year after enrollment
|
Extracranial hemorrhage within 1 year after enrollment (gastrointestinal bleeding, hematuria, epistaxis or fundus hemorrhage, etc.). |
Within 1 year after enrollment
|
|
Percentage of Participants With All-Cause Mortality Within 1 Year After Enrollment
Časové okno: Within 1 year after enrollment
|
All cause death within 1 year after enrollment. |
Within 1 year after enrollment
|
|
Percentage of Participants With Stroke-Related Mortality Within 1 Year After Enrollment
Časové okno: Within 1 year after enrollment
|
Stroke related death within 1 year after enrollment. |
Within 1 year after enrollment
|
|
Percentage of Participants With Other Serious Adverse Events Within 1 Year After Enrollment
Časové okno: Within 1 year after enrollment
|
Other serious adverse events within 1 year after enrollment. |
Within 1 year after enrollment
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes in Target-Vessel Imaging Characteristics Assessed by High-Resolution MRI at 1 Year (±1 Month) After Enrollment
Časové okno: 1 year (± 1 month) after enrollment
|
High-resolution MRI will be used to characterize interval changes in the vessel wall and atherosclerotic plaque of the qualifying artery, including plaque enhancement and other morphological characteristics, as applicable. |
1 year (± 1 month) after enrollment
|
|
Percentage of Participants With Recurrent Ischemic Stroke in Any Vascular Territory Within 3 Years After Enrollment
Časové okno: Within 3 years after enrollment
|
Recurrence of ischemic stroke in any region within 3 years after enrollment. |
Within 3 years after enrollment
|
|
Percentage of Participants With Recurrent Ischemic Stroke in the Territory of the Qualifying Artery Within 3 Years After Enrollment
Časové okno: Within 3 years after enrollment
|
Recurrence of ischemic stroke in target vessel area within 3 years after enrollment. |
Within 3 years after enrollment
|
|
Percentage of Participants With Recurrent TIA in the Territory of the Qualifying Artery Within 3 Years After Enrollment
Časové okno: Within 3 years after enrollment
|
TIA recurrence in target vessel area within 3 years after enrollment. |
Within 3 years after enrollment
|
|
Percentage of Participants With Recurrent TIA in Any Vascular Territory Within 3 Years After Enrollment
Časové okno: Within 3 years after enrollment
|
TIA recurrence in any region within 3 years after enrollment. |
Within 3 years after enrollment
|
|
Percentage of Participants Undergoing Target-Vessel Revascularization Within 3 Years After Enrollment
Časové okno: Within 3 years after enrollment
|
Salvage revascularization of target vessels within 3 years after enrollment (mechanical thrombectomy/arterial thrombolysis/angioplasty/vascular bypass). |
Within 3 years after enrollment
|
|
Percentage of Participants With Coronary Ischemic Events Within 3 Years After Enrollment
Časové okno: Within 3 years after enrollment
|
Coronary ischemic events within 3 years after enrollment (including myocardial infarction or angina pectoris). |
Within 3 years after enrollment
|
|
Modified Rankin Scale (mRS) Score at 3 Years After Enrollment
Časové okno: 3 years after enrollment
|
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death. |
3 years after enrollment
|
|
Q-5D Score at 3 Years After Enrollment
Časové okno: 3 years after enrollment
|
The change in functional health status and quality of life measured by EuroQol five dimensions questionnaire (EQ-5D) at 3 years after enrollment. |
3 years after enrollment
|
|
Target vessel restenosis at 3 years after enrollment (only the experimental group, evaluated by CTA)
Časové okno: 3 years after enrollment
|
Target vessel restenosis at 3 years after enrollment (only the experimental group, evaluated by CTA). |
3 years after enrollment
|
|
Percentage of Participants With Target-Vessel Restenosis at 3 Years After Enrollment in the Experimental Group
Časové okno: 3 years after enrollment
|
Symptomatic restenosis of target vessels at 3 years after enrollment (evaluation only in the experimental group). |
3 years after enrollment
|
|
Percentage of Participants With Hemorrhagic Stroke Within 3 Years After Enrollment
Časové okno: Within 3 years after enrollment
|
Hemorrhagic stroke within 3 years after enrollment (cerebral hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc.). |
Within 3 years after enrollment
|
|
Percentage of Participants With Extracranial Hemorrhage Within 3 Years After Enrollment
Časové okno: Within 3 years after enrollment
|
Extracranial hemorrhage within 3 years after enrollment (gastrointestinal bleeding, hematuria, epistaxis or fundus hemorrhage, etc.). |
Within 3 years after enrollment
|
|
Percentage of Participants With All-Cause Mortality Within 3 Years After Enrollment
Časové okno: Within 3 years after enrollment
|
All cause death within 3 years after enrollment. |
Within 3 years after enrollment
|
|
Percentage of Participants With Stroke-Related Mortality Within 3 Years After Enrollment
Časové okno: Within 3 years after enrollment
|
Stroke related death within 3 years after enrollment. |
Within 3 years after enrollment
|
|
Percentage of Participants With Other Serious Adverse Events Within 3 Years After Enrollment
Časové okno: Within 3 years after enrollment
|
Other serious adverse events within 3 years after enrollment. |
Within 3 years after enrollment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Changchun Jiang, MD, Baotou Central Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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