이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Drug-Coated Balloon vs Aggressive Medical Management for High-Risk Symptomatic Intracranial Atherosclerotic Stenosis (DRBEYOND2)

2026년 9월 20일 업데이트: Dapeng Mo, Beijing Tiantan Hospital

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

570

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100010
        • Beijing Tiantan Hospital
    • Inner Mongolia
      • Baotou, Inner Mongolia, 중국, 014000
        • Baotou Central Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Age 18-80 years old, regardless of gender
  2. 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
  3. 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
  4. 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)
  5. Those who voluntarily participated in the study and signed the informed consent

Exclusion Criteria:

  1. Serious calcification of target vessels, or serious distortion of target vessels or anatomical factors make it difficult for interventional instruments to be in place
  2. Severe stenosis or occlusion of extracranial or intracranial vessels in series at the proximal or distal end of the target vessel
  3. Major surgical operations have been performed in recent 3 weeks
  4. 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
  5. The target lesion has undergone stent implantation before
  6. Intracranial artery stenosis caused by non atherosclerotic lesions, including but not limited to: arterial dissection, moyamoya disease, vasculitis, radiation vascular disease or fibromuscular dysplasia
  7. mRS score ≥ 3
  8. Patients with coagulation dysfunction
  9. 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
  10. 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
  11. 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
  12. Pregnant or lactating women, or those who plan to become pregnant within one year
  13. 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
  14. Other cases that clinicians think should be excluded

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: Drug-Coated Balloon Angioplasty

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.
활성 비교기: 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.
다른: Aggressive Medical Management

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Any stroke or death within 30 days after enrollment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Within 1 year after enrollment

Other serious adverse events within 1 year after enrollment.
Within 1 year after enrollment

기타 결과 측정

결과 측정
측정값 설명
기간
Changes in Target-Vessel Imaging Characteristics Assessed by High-Resolution MRI at 1 Year (±1 Month) After Enrollment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Within 3 years after enrollment

Other serious adverse events within 3 years after enrollment.
Within 3 years after enrollment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beijing Tiantan Hospital

협력자

Baotou Central Hospital

수사관

  • 수석 연구원: Changchun Jiang, MD, Baotou Central Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2031년 6월 1일

연구 등록 날짜

최초 제출

2026년 9월 15일

QC 기준을 충족하는 최초 제출

2026년 9월 15일

처음 게시됨 (실제)

2026년 9월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 20일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HX-A-2026071-001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다