- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02256449
REPARA Study: REgistry of PAtients With bioResorbable Device in Daily Clinical prActice (REPARA)
Registry of Patients With Bioresorbable Device in Daily Clinical Practice. REPARA Study
연구 개요
상세 설명
The patients will be included consecutively at each site for one year. They will be individuals from both sexes, requiring endovascular intervention and meeting the authorised criteria for the indications of use of the device to be used and where dual anti-platelet therapy (DAPT) with aspirin and thienopyridines is considered.
STUDY OBJECTIVES To evaluate the MACE rate after implantation of the bioresorbable coronary device in patients with de novo coronary artery lesions, where a follow-up of 12 months will be performed.
Primary objective:
MACE rate at 12 months of follow-up:
Cardiac death Myocardial infarction TLR driven by ischaemia of the lesion treated or of the region of 5 mm proximally or distally to the site of implantation of the device (ID-TLR).
Secondary objectives:
- Angina
- Death due to any cause.
- Myocardial infarction of any type (MI: QMI, NQMI, TV, NTV)
- All TLR driven or not by ischaemia
- All TVR driven or not by ischaemia.
- All coronary revascularisations performed (PCI vs CABG)
- Device thrombosis (acute, sub-acute, late) and evidence (definitive, probable, possible).
- Immediate success of the device.
- Immediate success of the procedure.
- Rate of patients with DAPT at < 1 month, 1-3 months, 3-6 months, and 6-12 months and relationship with the occurrence of events
- Composite endpoints:
Cardiac death, TV-MI and ID-TLR: (Target Lesion Failure (TLF)) Cardiac death, any myocardial infarction (MI) and ID-TVR: (Target Vessel Failure (TVF))
- Rate of overlapping devices: characteristics and relationship with occurrence of events
- Collection of imaging data of the cases where, according to the judgement of the investigator, intravascular imaging tests have been performed (IVUS, OCT).
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Madrid, 스페인, 28041
- Hospital 12 de Octubre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patient must be at least 18 years of age at the time of signing the Informed Consent Form
- Patient is to be treated for de novo coronary lesions in a native coronary artery and amenable to receive a bioresorbable device
- The length of the treated lesion should be inferior to the nominal length of the device (12 mm, 18 mm, 28 mm) with a reference vessel diameter > 2 mm y < 3,8 mm.
- The patient will not have any relative contraindication for double antiplatelet therapy, with aspirin indefinitely and with a thienopyridine for at least 6 months
Exclusion Criteria:
- Cardiogenic shock
- Left main disease
- Aortocoronary graft
- Intrastent restenosis
- Potentially child-bearing women with no contraceptive methods
- Pregnant or breast-feeding women
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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BVS patients
Use of bioresorbable coronary device, according to the indications of use, in daily clinical practice, in patients undergoing PCI in de novo coronary artery lesions.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR
기간: Clinical follow-up at 12 months
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Clinical follow-up at 12 months
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Immediate success of the device/procedure
기간: 1 day
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1 day
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심장사
기간: 12 개월
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12 개월
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심근 경색증
기간: 12 개월
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12 개월
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Scaffold/Stent Thrombosis: Timing and Evidence
기간: 12 months
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12 months
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Target lesion/vessel revascularization (TLR/TVR)
기간: 12 months
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12 months
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Angina Events
기간: 12 months
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12 months
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Rate of patients with DAPT at 12 months
기간: 12 months
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12 months
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Rate of overlapping devices and characteristics
기간: 12 months
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Felipe Hernandez, MD, Seccion Hemodinamica y Cardiologia Intervencionista
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- COR-BVS-2013-01
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