- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00232804
The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
Safety and Efficacy Registry of Bx Cypher Stent in the Revascularisation of Patients With Significant Risk of Restenosis
The objective of this study is to establish the safety and efficacy of the treatment with Cypher DES in diabetic patients with documented ischemia due to stenosis (small coronary artery 2.5 -3 mm in lumen diameter, with lesion between 15 mm 30 mm in length, ) in native coronary arteries.
The objective of this study is to document that the use of Cypher DES in these diabetic patients undergoing percutaneous revascularization for stenosis is safe.
Safety will be assessed over a period of 12 months.
연구 개요
상세 설명
This is a prospective, multicenter, comparative, non randomised, open registry of 1000 patients who will be followed up to 12 months at 100 sites in France.
Patients will be screened according to normal practice and in relation to the inclusion and exclusion criteria. Patients should have a documented ischemia related to the target vessel.
Procedure of stent placement should be done under existing in hospital procedural protocol and care should be taken to follow Cordis instructions as set forth in the Instructions For Use.
Follow up will be done according to normal procedure and the minimum should be a telephone contact at 1, 6 and 12 months.
All data gathered during the enrollment, procedure, follow up and when specific events to the patient may occur, will be entered into the Internet CRF form, by the treating physician or a person from his staff specifically appointed to this task.
Patient enrollment is anticipated to last 8 months.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Lille, 프랑스, 59037
- Université de Lille, Hôpital cardiologique
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- NIDDM treated with oral antidiabetics for at least 3 months, or IDDM treated for at least 3 months with documented HbA1C;
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia;
- Target lesion stenosis is >50% (visual estimate);
- Target vessel diameter, between 2.5 and 3.0 mm
- Target lesion length minimum 15 mm and maximum 30mm
Exclusion Criteria:
- CK and CK-MB enzymes above normal or elevated troponin level (as determined by site criteria) at the time of treatment;
- Has unstable angina classified as Braunwald III B and A or C I-II-III, or is having a peri-infarction;
- Unprotected left main coronary disease with >=50% stenosis;
- Significant (>50%) stenosis proximal or distal to the target lesion that might impede inflow or runoff and can not be revascularized before or during the index procedure;
- Have an ostial target lesion;
- Documented left ventricular ejection fraction <=30%;
- In-Stent restenosis;
- Chronic total occlusion.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 1
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
MACE.
기간: 1, 6, and 12 months post-procedure
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1, 6, and 12 months post-procedure
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Lablanche, Prof., Université de Lille, Hôpital cardiologique
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
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 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. .