Endovascular Treatment Group 및 Standard medication의 허혈성 뇌졸중 및 Intracranial Large Vessel Occlusion - 임상 시험 레지스트리

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Patients with ischemic stroke whose onset or last known well (LKW) ranged from 24 hours to 30 days, who were confirmed by imaging to have intracranial large vessel occlusion and may still have brain tissue that can be saved were included. The study did not interfere with the choice of treatment options. Patients received intravascular therapy or standard drug treatment, which was determined by clinicians according to the condition, imaging characteristics and the joint decision of doctors and patients. According to the actual treatment of patients, the intravascular treatment cohort and the standard drug treatment cohort were formed, in which the intravascular treatment was centered on the COSIS distal stent protection strategy. The primary outcome is proportion of patients with functional independence defined as mRS score of 0-2 at 90 days after enrollment.

연구 유형

관찰

등록 (추정된)

150

연락처 및 위치

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

연구 연락처

이름: Xuan Sun, MD
전화번호: 13810926284
이메일: sxuan@yeah.net

연구 장소

중국
- Beijing Municipality
  - Beijing, Beijing Municipality, 중국, 100070
    - Beijing Tiantan Hospitall, Capital Medical University
    - 연락하다:
      
      Xuan Sun, MD
      
      전화번호: +8613810926284
      
      이메일: sxuan@yeah.net

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

All research centers continuously screened eligible patients according to unified standards. The study did not interfere with the choice of treatment options. Whether the patients received intravascular therapy was determined by clinicians according to the condition, imaging characteristics, treatment risk and the joint decision of doctors and patients.

This is a prospective multicenter observational registry-based cohort study. Endovascular treatment is a routine clinical interventional procedure. The decision whether to perform endovascular treatment is made by treating clinicians, not assigned by study investigators. Investigators only collect real-world clinical data and follow-up outcomes of enrolled participants.

설명

Inclusion Criteria:

Age≥18 years
The clinical diagnosis was ischemic stroke, and imaging confirmed the presence of intracranial large vessel occlusion
The time from LKW or the time of finding symptoms is 24 hours to 72 hours; or more than 72 hours but not more than 30 days, and there are neurological deterioration or fluctuation
Imaging findings suggest that there may still be salvageable brain tissue, which meets any of the following conditions: perfusion imaging examination shows that the ischemic core volume < 70 ml and the mismatch ratio > 1.2; CTA or DSA showed moderate or good collateral circulation; MRI-DWI showed a significant mismatch between lesion size and clinical symptoms
The modified Rankin Scale score (mRS) before onset was 0-1
The subjects themselves or their legal representatives voluntarily participated in the study and signed written informed consent

Exclusion Criteria:

Large area cerebral infarction or imaging showed obvious space occupying effect, such as ASPECTS<6 points,or brainstem infarction area exceeded 1/3 of the corresponding anatomical area
Isolated extracranial carotid or vertebral artery occlusion
Intracranial tumors, arteriovenous malformations or other serious intracranial diseases that may significantly affect the evaluation of the outcome of the study
Intracranial hemorrhage occurred in the past 3 months
There is a risk of severe coagulation dysfunction, active bleeding or other high bleeding that cannot be corrected
Severe liver and kidney function damage, which may affect treatment or follow-up
Pregnant or lactating women
The estimated survival time is less than 1 year
Unable to complete 90-day clinical follow-up or main outcome assessment
Participating in other interventional clinical trials that may affect the treatment or outcome evaluation of this study
Other circumstances that the researcher believes are not suitable for participating in this study

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: COHORT
시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
Endovascular Treatment Cohort Intravascular therapy combined with standard drug therapy, in which the core of intravascular therapy is the cosis distal stent protection strategy.	절차: Endovascular Treatment Group The recanalization strategy with COSIS distal stent protection technology as the core was used in endovascular treatment.In addition to thrombus removal, the device mainly uses its distal closed basket structure and stent guide wire to form protection and anchor fulcrum at the distal end of occlusion, so as to assist in balloon dilatation, thrombus removal or stent implantation of complex occlusive lesions, and reduce thrombus escape.
Standard Medical Therapy Cohort Standard drug therapy alone.It mainly includes antiplatelet therapy or anticoagulation therapy, lipid-lowering therapy, blood pressure and blood glucose management, etc.	다른: Standard medication Standard drug therapy is implemented in accordance with the current guidelines for the diagnosis and treatment of cerebrovascular diseases and the routine of each center, mainly including antiplatelet or anticoagulation therapy, lipid-lowering therapy, blood pressure and blood glucose management, etc. The drug name, dose, route of administration, frequency of administration and course of treatment are determined by the clinician according to the patient's condition. The study only recorded the actual drug treatment and important adjustments.

그룹/코호트

개입 / 치료

Endovascular Treatment Cohort

Intravascular therapy combined with standard drug therapy, in which the core of intravascular therapy is the cosis distal stent protection strategy.

절차: Endovascular Treatment Group

The recanalization strategy with COSIS distal stent protection technology as the core was used in endovascular treatment.In addition to thrombus removal, the device mainly uses its distal closed basket structure and stent guide wire to form protection and anchor fulcrum at the distal end of occlusion, so as to assist in balloon dilatation, thrombus removal or stent implantation of complex occlusive lesions, and reduce thrombus escape.

Standard Medical Therapy Cohort

Standard drug therapy alone.It mainly includes antiplatelet therapy or anticoagulation therapy, lipid-lowering therapy, blood pressure and blood glucose management, etc.

다른: Standard medication

Standard drug therapy is implemented in accordance with the current guidelines for the diagnosis and treatment of cerebrovascular diseases and the routine of each center, mainly including antiplatelet or anticoagulation therapy, lipid-lowering therapy, blood pressure and blood glucose management, etc.

The drug name, dose, route of administration, frequency of administration and course of treatment are determined by the clinician according to the patient's condition. The study only recorded the actual drug treatment and important adjustments.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
The proportion of patients with functional independence defined as mRS score of 0 - 2 at 90 days after enrollment 기간: 90 days 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.	90 days after enrollment

2차 결과 측정

기타 결과 측정

결과 측정	측정값 설명	기간
Adverse events within 12 months after enrollment 기간: 12 months after enrollment	Adverse events events within 12 months after enrollment.	12 months after enrollment
Serious adverse events within 12 months after enrollment 기간: 12 months after enrollment	Serious adverse events within 12 months after enrollment.	12 months after enrollment
Symptomatic intracranial hemorrhage within 12 months after enrollment 기간: 12 months after enrollment	Symptomatic intracranial hemorrhage within 12 months after enrollment.	12 months after enrollment
Ischemic stroke within 12 months after enrollment 기간: 12 months after enrollment	Ischemic stroke within 12 months after enrollment.	12 months after enrollment
Hemorrhagic stroke within 12 months after enrollment 기간: 12 months after enrollment	Hemorrhagic stroke within 12 months after enrollment.	12 months after enrollment
All-cause death and other important clinical safety events within 12 months after enrollment 기간: 12 months after enrollment	All-cause death and other important clinical safety events within 12 months after enrollment.	12 months after enrollment
Proportion of at least one complication in the intravascular therapy cohort 기간: Perioperative	The intravascular treatment cohort included perioperative vascular dissection, vascular perforation or rupture, distal embolization, acute occlusion, re-occlusion, cerebral hyperperfusion syndrome and puncture site complications.	Perioperative

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Xuan Sun

수사관

수석 연구원: Xuan Sun, MD, Beijing Tiantan 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)

2029년 12월 31일

연구 등록 날짜

최초 제출

2026년 9월 9일

QC 기준을 충족하는 최초 제출

2026년 9월 21일

처음 게시됨 (실제)

2026년 9월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 21일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

HX-A-2026022

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. .

결과 측정	측정값 설명	기간
The overall distribution of mRS at 90 days after enrollment 기간: 90 days 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.	90 days after enrollment
National Institutes of Health Stroke Scale (NIHSS) score 24 hours after treatment 기간: 24 hours after treatment	The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.	24 hours after treatment
National Institutes of Health Stroke Scale (NIHSS) score at discharge 기간: At discharge	The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.	At discharge
National Institutes of Health Stroke Scale (NIHSS) score 30 days after enrollment 기간: 30 days after enrollment	The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.	30 days after enrollment
National Institutes of Health Stroke Scale (NIHSS) score 90 days after enrollment 기간: 90 days after enrollment	The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.	90 days after enrollment
The recurrence rate of stroke within 90 days after enrollment 기간: 90 days after enrollment	The recurrence rate of stroke within 90 days after enrollment.	90 days after enrollment
Transient ischemic attack within 90 days after enrollment 기간: 90 days after enrollment	Transient ischemic attack within 90 days after enrollment.	90 days after enrollment
All-cause mortality within 90 days after enrollment 기간: 90 days after enrollment	All-cause mortality within 90 days after enrollment.	90 days after enrollment
Revascularization of target vessels within 90 days after enrollment 기간: 90 days after enrollment	Revascularization of target vessels within 90 days after enrollment.	90 days after enrollment
The technical success rate of the intravascular treatment cohort，successful recanalization of the target vessel with residual stenosis <50% and final mTICI grade≥2b 기간: At the end of the procedure	The technical success rate of the intravascular treatment cohort，successful recanalization of the target vessel with residual stenosis <50% and final mTICI grade≥2b.	At the end of the procedure
Degree of recanalization in the intravascular treatment cohort 기간: At the end of the procedure	Degree of recanalization in the intravascular treatment cohort.The mTICI scale evaluates angiographic recanalization after endovascular therapy for acute ischemic stroke. Grades range from 0 (no perfusion) to 3 (complete recanalization). mTICI grade≥2b is defined as successful recanalization.	At the end of the procedure
Operation time of intravascular treatment cohort 기간: During the procedure	Operation time of intravascular treatment cohort.	During the procedure
Distribution of mRS scores at 6 months after enrollment 기간: 6 months 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.	6 months after enrollment
The recurrence rate of stroke at 6 months after enrollment 기간: 6 months after enrollment	The recurrence rate of stroke at 6 months after enrollment.	6 months after enrollment
Transient ischemic attack at 6 months after enrollment 기간: 6 months after enrollment	Transient ischemic attack at 6 months after enrollment.	6 months after enrollment
All-cause mortality at 6 months after enrollment 기간: 6 months after enrollment	All-cause mortality at 6 months after enrollment.	6 months after enrollment
Revascularization of target vessels at 6 months after enrollment 기간: 6 months after enrollment	Revascularization of target vessels at 6 months after enrollment.	6 months after enrollment
Distribution of mRS scores at 12 months after enrollment 기간: 12 months 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.	12 months after enrollment
The recurrence rate of stroke at 12 months after enrollment 기간: 12 months after enrollment	The recurrence rate of stroke at 12 months after enrollment.	12 months after enrollment
Transient ischemic attack at 12 months after enrollment 기간: 12 months after enrollment	Transient ischemic attack at 12 months after enrollment.	12 months after enrollment
All-cause mortality at 12 months after enrollment 기간: 12 months after enrollment	All-cause mortality at 12 months after enrollment.	12 months after enrollment
Revascularization of target vessels at 12 months after enrollment 기간: 12 months after enrollment	Revascularization of target vessels at 12 months after enrollment.	12 months after enrollment

EndovascularTherapy Versus Standard Medical Terapy for Intracranial Large Vessel Occlusion in 24 Hours to 30 Days

EndovascularTherapy Versus Standard Medical Terapy for Intracranial Large Vessel Occlusion in 24 Hours to 30 Days: A Prospective, Multicenter, Real-world Cohort Trial

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (추정된)

연락처 및 위치

연구 연락처

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

샘플링 방법

연구 인구

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

기타 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

수사관

연구 기록 날짜

연구 주요 날짜

연구 시작 (추정된)

기본 완료 (추정된)

연구 완료 (추정된)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구