- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07455747
ENROUTE™ 경경동맥 신경보호 시스템을 이용한 두개외 경동맥 질환의 실제 임상 치료 (ENTRUST)
ENROUTE™ 경동맥 신경보호 시스템(ENTRUST)을 이용한 두개외 경동맥 질환의 실제 임상 치료
The ENTRUST registry's objective is to collect real-world data (RWD) and health economic data on the ENROUTE™ Transcarotid Neuroprotection System (ENROUTE™ Transcarotid NPS), including populations in which outcomes of Transcarotid Artery Revascularization (TCAR) in patients with extracranial carotid artery disease are inadequately reported.
연구 개요
상태
상세 설명
A global prospective, single-arm, non-randomized, open-label, observational/non-interventional, multi-center registry to collect Real-World Data for TCAR procedure, including health economic data.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Erin Hammer
- 전화번호: 952-356-2730
- 이메일: Erin.Hammer@bsci.com
연구 장소
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Missouri
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St Louis, Missouri, 미국, 63141
- 모병
- St. Luke's Episcopal-Presbyterian Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
The intended population for the ENTRUST Registry are real-world patients who are treated with ENROUTE™ Transcarotid NPS in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease. Efforts will be made to include study centers with varied patient populations in order to enroll populations previously not represented in carotid artery disease trials.
설명
Inclusion Criteria:
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Patient is ≥ 18 years of age*
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Written informed consent (patient data-release form)
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Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease and specified in the Registry Enrollment Guide(s).
- Refer to the Registry Enrollment Guide for details on enrollment restrictions based on patient age
Exclusion Criteria:
- Life expectancy of < 1 year or patient is unlikely to derive net clinical benefit from carotid revascularization.
- Patient has primary, recurrent or metastatic malignancy and does not have independent assessment of life expectancy of ≥5 years performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Clinical Cohort
All enrolled patients are included in the Clinical Cohort. Patients will complete assessments per standard of care through 12-months in North America. |
ENROUTE™ Transcarotid NPS AND ENROUTE™ Transcarotid Stent System. Additionally, ENROUTE™ Transcarotid NPS AND any commercially available Boston Scientific stent marketed for treatment of carotid artery disease may be added upon commercial availability. |
|
Extended Clinical Cohort
Patients who elect to be followed through 36 months are included in the Extended Clinical Cohort. Patients will complete assessments per standard of care through 36-months in North America. |
ENROUTE™ Transcarotid NPS AND ENROUTE™ Transcarotid Stent System. Additionally, ENROUTE™ Transcarotid NPS AND any commercially available Boston Scientific stent marketed for treatment of carotid artery disease may be added upon commercial availability. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Major Adverse Events
기간: within 30 days (death, stroke, or MI); within 31-365 days (ipsilateral stroke)
|
Major Adverse Events (MAEs) defined as a composite outcome including any death, stroke, or myocardial infarction (MI) within 30 days of the index procedure and ipsilateral stroke within 31 days to 365 days of the index procedure. No pre-specified endpoints or formal tests of hypotheses are proposed. Analyses will be performed for exploratory purposes. |
within 30 days (death, stroke, or MI); within 31-365 days (ipsilateral stroke)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Angela H Martin, MD, Evansville Surgical Associates
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 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. .