- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02029092
BIOFLOW III Satellite-ELADIS Orsiro Stent System
BIOTRONIK- Safety and Performance Registry for an All Comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice III- ELADIS
연구 개요
상태
정황
상세 설명
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.
The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical performance and safety of ORSIRO drug eluting stent system in daily clinical practice.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Badajoz, 스페인
- Hospital Infanta Cristina
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Barcelona, 스페인
- Hospital Vall d' Hebron
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Cadiz, 스페인
- Hospital G.de Jerez de la Frontera
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Gasteiz / Vitoria, 스페인
- Hospital de Txagorritxu
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Murcia, 스페인
- Hospital Univ. Virgen de la Arrixaca
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Mérida, 스페인
- Hospital de Merida
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Sabadell, 스페인
- Hospital Parc Tauli
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Santiago de Compostela, 스페인, 15702
- Complejo de Hospitalario de Santiago
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Sevilla, 스페인
- Hospital Virgen del Rocío
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Terrassa, 스페인
- Hospital Mutua de Terrassa
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Valencia, 스페인
- Hospital Clinico de Valencia
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Valencia, 스페인
- Hospital Doctor Peset
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Vizcaya, 스페인, 48903
- Hospital de Cruces
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A/Altos de Nava s/n
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León, A/Altos de Nava s/n, 스페인, 24080
- Hospital Universitario León
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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:
- Symptomatic coronary artery disease
- Subject has signed informed consent for data release
- Subject is geographically stable and willing to participate at all follow up assessments
- Subject is≥18 years of age.
Exclusion Criteria:
- Subject did not sign informed consent for data release
- Pregnancy
- Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation, antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media.
- Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint is not yet reached.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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오르시로
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
표적 병변 실패(TLF)
기간: 12 개월
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심장사, 표적 혈관 Q파 또는 비Q파 심근경색증(MI), 관상동맥우회술(CABG) 및 임상적으로 유도된 표적 병변 재관류술(TLR)의 복합.
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12 개월
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
TLF
기간: 6 months
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Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).
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6 months
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Target Vessel Revascularization (TVR)
기간: 6 and 12 months
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Target Vessel Revascularization (TVR)
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6 and 12 months
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Target lesion revascularization (TLR)
기간: 6 and 12 months
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Target lesion revascularization (TLR)
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6 and 12 months
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Stent Thrombosis rate
기간: 6 and 12 months
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Stent Thrombosis rate
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6 and 12 months
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Device success
기간: up to discharge
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Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device outside the assigned treatment strategy
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up to discharge
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Procedure success
기간: up to 7 days after procedure
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Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device and without the occurrence of ischemia-driven major cardiac event during the hospital stay to a maximum of the first seven days post index procedure.
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up to 7 days after procedure
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공동 작업자 및 조사자
수사관
- 연구 책임자: Sonia Martin, CEM BIOTRONIK SA
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
- G1302
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. .
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