RESOLUTE China Registry: (R-C Registry)
Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China
연구 개요
상세 설명
The Resolute stent is designed to support the approach of delivering drug to the coronary arterial tissue over a longer period of time than that offered by current approved DES products. This method of prolonged drug elution may address the need to control local vascular neointimal proliferation in patients with complex lesions for extended therapeutic effect. The purpose of this multi-center trial is to investigate the clinical safety and efficacy of the Endeavor Resolute drug-eluting stent in every-day patients, like stable and unstable patients with single or multi-vessel disease and/or complex lesions.
Patients should be treated according to normal hospital routine practice and in line with the applicable guidelines on percutaneous coronary interventions and the Instructions For Use of the device.
1800 patients will be enrolled from China at approximately 40 centers where Endeavor Resolute stent is commercially available.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Beijing, 중국, 100000
- Beijing Fumwai Hospital
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Beijing, 중국, 100044
- Peiking University People's Hospital
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Fuzhou, 중국, 350001
- Fujian Medical University Union Hospital
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Guangdong, 중국, 510000
- Guangdong Provincial People's Hospital
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Nanjing, 중국, 210006
- Nanjing First Hospital
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Wuhan, 중국, 430022
- Wuhan Asia Heart Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the Resolute Zotarolimus-Eluting Coronary Stent System.
All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Resolute stent in one or more target lesions are candidates to be enrolled.
설명
Inclusion Criteria:
Patient must meet all of the following criteria to be eligible for treatment in the trial:
- Age ≥ 18 years or minimum age as required by local regulations
- The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute stent and the Declaration of Helsinki
- The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
- Intention to electively implant at least one Resolute stent
- The patient is willing and able to cooperate with study procedures and required follow up visits
Exclusion Criteria:
Patients will be excluded from the trial if any of the following criteria are met:
- Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. Biolinx), zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
- Women with known pregnancy or who are lactating
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
- Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
- Previous enrollment in the Resolute China Registry
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 전용
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Target lesion failure (TLF)
기간: 12m
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Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods at 1 year.
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12m
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall stent thrombosis
기간: 12m
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Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.
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12m
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Device success, Lesion success, Procedural success
기간: At the end of the index procedure or during hospital stay
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At the end of the index procedure or during hospital stay
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TLF
기간: 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
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Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods will be assessed at 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
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30 days, 6 months, 2 year, 3 year, 4 year and 5 year
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All deaths (cardiac, vascular and non-cardiovascular)
기간: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Stent thrombosis rate
기간: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition)
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Myocardial infarction
기간: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Q wave and non-Q wave MI
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Revascularization
기간: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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target lesion and target vessel revascularization (TLR and TVR)
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Significant bleeding complications and stroke
기간: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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hemorrhagic in nature
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Target vessel failure (TVF)
기간: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Major adverse cardiac events (MACE)
기간: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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a composite endpoint of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jiyan Chen, MD, Guangdong Provincial People's Hospital
- 수석 연구원: Shubin Qiao, MD, Fu Wai Hospital, Beijing, China
- 수석 연구원: Lianglong Chen, MD, Fujian Medical University Union Hospital
- 수석 연구원: Shaoliang Chen, MD, The First Affiliated Hospital with Nanjing Medical University
- 수석 연구원: Weimin Wang, MD, Peiking University People's Hospital
- 수석 연구원: Guoying Zhu, MD, Wuhan Asia Heart Hospital
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- IP124
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심혈관 질환에 대한 임상 시험
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University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국