- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04150016
In-stent Repair and Vessel Reaction of STEMI Patients With OCT
Assessment of In-stent Intimal Repair and Vessel Reaction After FirehawkTM Sirolimus Eluting Stent Implantation of STEMI Subjects - An Optical Coherence Tomography (OCT) Study
연구 개요
상태
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Tao Ling, Doctor
- 전화번호: 15002955798
- 이메일: lingtao@fmmu.edu.cn
연구 장소
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Shanxi
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Xi'an, Shanxi, 중국
- 모병
- Xijing Hospital
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연락하다:
- Tao Ling, Doctor
- 이메일: lingtao@fmmu.edu.cn
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Clinical Inclusion Criteria:
CI1. Subject must be 18 - 75 years of age; male or female without pregnancy.
CI2. Subjects recently suffer from SETMI (from 20 minute to 12 hours), and ECG changes consistent with AMI:
- 1mm elevation in more than 2 continuously leads, or; Newly developed LBBB, or;
- 1mm depression in more than 2 continuously leads representing Posterior myocardial infarction) CI3. New, in situ and single or bifurcation lesion of target vessel. CI4. Subject only implanted one brand of stent. CI5. Subjects are eligible candidates for coronary artery bypass graft surgery (CABG).
CI6. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
Angiographic Inclusion Criteria:
AI1. At least one of the target lesions must be acute occlusion lesion, and Eligible for percutaneous coronary intervention (PCI), and Having a visually estimated diameter restenosis no less than 70% (or a visually estimated diameter restenosis no less than 50% with consistent clinical symptoms), TIMI blood flow no less than Grade I, and have a visually estimated reference diameter ≥2.25 mm and ≤4.0 mm.
AI2. Target lesions must be able to pass through all target lesions (no severe tortuosity or calcification in proximal lesion).
AI3. Target lesions of type A lesion defined by ACC/AHA must be successfully expanded (no severe calcification in target lesion).
Clinical Exclusion Criteria:
CE1. Subjects with Cardiogenic shock. CE2. Subjects with severe heart failure (NYHA classification ≥ 3) or LVEF<35%. CE3. Subjects with elevated serum creatinine level >2.0mg/dL or undergoing dialysis therapy.
CE4. Subjects associated with drugs allergy (such as sirolimus, everolimus, stent alloys, contrast medium, heparin, clopidogrel or aspirin).
CE5. Subjects with bleeding tendency, active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion.
CE6. Subjects with cardiac stroke or with sequelae of stroke. CE7. Subjects with cebral tumor, Cerebral aneurysms, cerebral arteriovenous malformation (AVM), transient ischemic attack (TIA), permanent nerve defects, GI bleeding within 2 months, major operation within 6 weeks, or with abnormal counts of platelet and hemoglobin (Hb): platelet counts less than 1×106/mm3, Hb less than 10g/dL.
CE8. Subjects plan to undergo any operations within 6 months that may lead to anti-platelet therapy discontinuation.
CE9. Subjects are suffering from other serious illness, which may cause drop in life expectancy to less than 12 months.
CE10. Subjects were participating in another study of drug or medical device, which did not meet its primary endpoint.
CE11. Subject are considered unwilling to understand the trial requirements and refused to follow the treatment procedures.
CE12. Subject with Heart transplantation.
Angiographic Exclusion Criteria:
AE1. Target lesions with true bifurcation lesion (both main and branch vessel need implantation).
AE2. Target lesions with unprotected left main. AE3. Target lesions with more than 100mm in length. AE4. Target lesions with in-stent stenosis. AE5. Uncertain target lesions. AE6. Target lesion unsuitable for 6 months OCT follow up.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Firehawk implantation
22 subjects will be enrolled to receive Firehawk™ sirolimus target-eluting stent(s).
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Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical procedure that improves blood flow to your heart.PCI requires cardiac catheterization, which is the insertion of a catheter tube and injection of contrast dye, usually iodine-based, into your coronary arteries.
Doctors use PCI to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque.
PCI may be used to relieve symptoms of coronary heart disease or to reduce heart damage during or after a heart attack.
다른 이름들:
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활성 비교기: XIENCE implantation
22 subjects will be enrolled to receive XIENCE™ everolimus target-eluting stent(s).
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Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical procedure that improves blood flow to your heart.PCI requires cardiac catheterization, which is the insertion of a catheter tube and injection of contrast dye, usually iodine-based, into your coronary arteries.
Doctors use PCI to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque.
PCI may be used to relieve symptoms of coronary heart disease or to reduce heart damage during or after a heart attack.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Neointimal thickness by OCT
기간: At 6 months post-index procedure
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At 6 months post-index procedure
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2차 결과 측정
결과 측정 |
기간 |
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Percentage of Uncovered Struts by OCT
기간: At 6 months post-index procedure
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At 6 months post-index procedure
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Target lesion failure
기간: 30 days, 6 months, 12 months post-index procedure
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30 days, 6 months, 12 months post-index procedure
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Percentage of Malaposition Struts by OCT
기간: At 6 months post-index procedure
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At 6 months post-index procedure
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Thrombosis (from ARC definition)
기간: 30 days, 6 months, 12 months post-index procedure
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30 days, 6 months, 12 months post-index procedure
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In-stent and in-segment late lumen loss
기간: At 6 months post-index procedure
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At 6 months post-index procedure
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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. .
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