THUNDER: Thunderbolt™ 흡인 튜브를 포함하는 Penumbra System®을 사용한 급성 허혈성 뇌졸중 연구
The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Arizona
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Goodyear, Arizona, 미국, 85395
- Abrazo West Campus
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California
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San Diego, California, 미국, 92123
- Sharp Grossmont
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Colorado
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Englewood, Colorado, 미국, 80113
- HRI - Swedish
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Connecticut
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New Haven, Connecticut, 미국, 06520
- Yale New Haven
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Delaware
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Newark, Delaware, 미국, 19718
- Christiana Care
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Florida
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Miami, Florida, 미국, 33136
- Jackson Memorial (U. of Miami)
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Tampa, Florida, 미국, 33614
- St. Joseph - BayCare
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Georgia
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Atlanta, Georgia, 미국, 30309
- Piedmont Hospital Atlanta
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Marietta, Georgia, 미국, 30060
- Wellstar Kennestone Hospital
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Illinois
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Evanston, Illinois, 미국, 60201
- North Shore U.
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Naperville, Illinois, 미국, 60540
- Edward Elmhurst Health
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana U. Health
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Kansas
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Kansas City, Kansas, 미국, 66160
- KUMC
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General
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Worcester, Massachusetts, 미국, 01655
- UMass Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, 미국, 55427
- Abbott Northwestern
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Mississippi
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Jackson, Mississippi, 미국, 39216
- St. Dominic
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Nebraska
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Omaha, Nebraska, 미국, 68198
- Nebraska Medical
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New York
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Albany, New York, 미국, 12208
- Albany Medical Center
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Buffalo, New York, 미국, 14203
- University of Buffalo
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Stony Brook, New York, 미국, 11794
- Stonybrook U.
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North Carolina
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Wilmington, North Carolina, 미국, 28401
- New Hanover Regional
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Pennsylvania
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Danville, Pennsylvania, 미국, 17822
- Geisinger Medical Center
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Philadelphia, Pennsylvania, 미국, 19107
- Thomas Jefferson University
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York, Pennsylvania, 미국, 17403
- Wellspan York
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South Carolina
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Charleston, South Carolina, 미국, 29425
- MUSC
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Tennessee
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Knoxville, Tennessee, 미국, 37916
- Fort Sanders
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Memphis, Tennessee, 미국, 38104
- Methodist U.
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Texas
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Houston, Texas, 미국, 77030
- UT Houston
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Tyler, Texas, 미국, 75702
- Christus Trinity Medical Center
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Virginia
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Newport News, Virginia, 미국, 23601
- Riverside Regional Medical Center
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Washington
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Renton, Washington, 미국, 98055
- Valley Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient age 18 - 80 years
- Treatment within 8 hours of symptom onset
- Pre-stroke mRS 0-2
- Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion in the internal carotid, middle cerebral (M1 or M2), basilar, or vertebral artery
- If patient is eligible for thrombolytic therapy, it was administered as soon as possible, and no later than 3 hours from stroke symptom onset
- Planned frontline treatment with Penumbra System including Thunderbolt modulated aspiration
- Informed consent obtained per Institution Review Board/Ethics Committee requirements
Exclusion Criteria:
- Stenosis, excessive tortuosity, or any occlusion in a proximal vessel requiring treatment or preventing access to the thrombus
- Alberta Stroke Program Early CT Score (ASPECTS) ≤6 or core infarct volume >50 mL on MRI or CT-based imaging (for anterior circulation strokes)
- Pregnant patient
- Life expectancy < 90 days due to comorbidities
- Current participation in an interventional drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies
- Other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Single Arm
Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy |
Subject will receive Penumbra System with Thunderbolt |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Efficacy Endpoint: Angiographic Revascularization
기간: Up to Procedure Completion
|
Angiographic revascularization of the occluded target vessel Post-Penumbra as defined by mTICI 2b or higher. *mTICI ranges from 0-3, with higher grading representing better outcome |
Up to Procedure Completion
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Efficacy Endpoint: Angiographic Revascularization After First Pass
기간: During Index Procedure
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Angiographic revascularization of the occluded target vessel after first pass as defined by mTICI 2b or higher *mTICI ranges from 0-3, with higher grading representing better outcome |
During Index Procedure
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Efficacy Endpoint: Angiographic Revascularization
기간: Up to Procedure Completion
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Angiographic revascularization of the occluded target vessel Post-Penumbra as defined by mTICI 2c or higher *mTICI ranges from 0-3, with higher grading representing better outcome |
Up to Procedure Completion
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Efficacy Endpoint: Time to Revascularization
기간: During Index Procedure
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Time from arterial puncture to successful revascularization of the target vessel (mTICI 2b-3), or to the final angiogram if successful revascularization is not achieved |
During Index Procedure
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Efficacy Endpoint: Modified Rankin Scale (mRS)
기간: 90 Days Post-Procedure
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Functional outcomes measured by mRS 0-2 at 90 days (0 no symptoms - 5 severe disability) |
90 Days Post-Procedure
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Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)
기간: 24 hours Post-Procedure
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Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours |
24 hours Post-Procedure
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Safety Endpoint: All-cause Mortality
기간: 90 Days Post-Procedure
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All-cause mortality at 90 days post-procedure |
90 Days Post-Procedure
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Safety Endpoint: Serious Adverse Events (SAEs)
기간: Up to 24 hours Post-Procedure
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Incidence of device related, and/or procedure related Serious Adverse Events (SAEs) within 24 hours post-procedure |
Up to 24 hours Post-Procedure
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Donald Frei, M.D., HCA HealthONE, LLC (Swedish Medical Center)
- 수석 연구원: David Fiorella, M.D., The Research Foundation for The State University of New York (Stony Brook University)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- 21340
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
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