Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH EFS)
Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System for Bifurcation Lesions (First-in-Human, Early Feasibility Study)
연구 개요
상태
개입 / 치료
상세 설명
This is a prospective, single-arm, single-center initial (EFS) clinical study enrolling subjects with symptomatic ischemic heart disease due to a de novo coronary bifurcation lesion. The objective is to obtain initial insights into the clinical safety of the device-specific aspects of the procedure; whether the device can be successfully delivered and implanted; whether there are any operator technique challenges with device use; human factors; clinical safety of the device and whether the device performs in accordance with its intended purpose.
All enrolled subjects will be treated with the study device during the index procedure and followed after treatment to assess procedural success, clinical safety, and device performance. Follow-up is conducted through 3 years.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Asunción, 파라과이
- Cirugía Cardiovascular, Sanatorio Italiano
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Be 21 years of age or older. Have symptomatic ischemic heart disease or objective evidence of reduced blood flow to the heart.
Be eligible for PCI, also known as coronary stenting. Have a new coronary artery narrowing involving a branch point that meets the study's angiographic requirements.
Be willing and able to complete study follow-up. Be able to provide written informed consent. If able to become pregnant, have a negative pregnancy test before the procedure and agree not to become pregnant or breastfeed for 1 year.
Exclusion Criteria:
Are currently participating in another investigational drug or device study that could interfere with this study.
Had a coronary intervention within 30 days before the planned study procedure. Need a planned additional coronary procedure soon after the study procedure. Had a prior stent placed close to the target lesion. Have a target lesion that requires certain other treatment devices before stent placement, other than balloon angioplasty or intravascular lithotripsy.
Have a serious medical condition that could limit participation, follow-up, or interpretation of the study results.
Have a life expectancy of less than 3 years. Have a condition requiring chronic immunosuppressive therapy or have a severe autoimmune or immunosuppressive condition.
Have significantly reduced heart pumping function. Had a recent acute heart attack, unless certain laboratory values have returned to acceptable levels.
Had a stroke or transient ischemic attack within the past 6 months. Have certain abnormal blood test results, including low white blood cell count, low neutrophil count, low platelet count, or significantly reduced kidney function.
Have active stomach or intestinal bleeding, active peptic ulcer disease, a bleeding disorder, or cannot receive blood transfusions.
Have a known allergy or contraindication to required medications, contrast dye, or study device materials that cannot be adequately managed.
Are pregnant, breastfeeding, or planning to become pregnant within 1 year after the study procedure.
Have coronary anatomy that is not suitable for the study device, as determined during coronary angiography (This may include blood clot in the target lesion, severe vessel tortuosity, severe calcification, certain lesion locations, or other significant disease in the target vessel).
Are unable or unwilling, in the opinion of the study doctor, to comply with the study requirements.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Patients with coronary bifurcation lesions
Patients undergoing PCI to treat a bifurcation lesion
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The MD-SBA DES System is a single use, minimally invasive combination product that consists of a cobalt chromium metal coronary stent, coated with sirolimus in a PEA/BHT matrix, on a rapid exchange (RX) delivery system.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Procedure Success
기간: Periprocedural
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To determine whether the device can be successfully delivered and implanted, as measured by attainment of <30% final residual stenosis of the target lesion and no in-hospital major adverse cardiac events (MACE).
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Periprocedural
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MACE
기간: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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Percentage of subjects with major adverse cardiac events, defined as cardiac death, myocardial infarction, emergency coronary artery bypass surgery, or clinically driven target lesion revascularization.
Components of MACE, including cardiac death and myocardial infarction, may also be summarized.
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30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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TVF
기간: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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Percentage of subjects with target vessel failure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization.
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30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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Target Lesion Revascularization of the Side Branch
기간: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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Percentage of subjects requiring repeat treatment of the side branch by percutaneous or surgical methods.
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30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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Stent thrombosis
기간: 6-months, 1-year, 2-years, and 3-years post index procedure
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Percentage of subjects with late stent thrombosis.
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6-months, 1-year, 2-years, and 3-years post index procedure
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Acute Success
기간: Index procedure
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Percentage of subjects with successful device delivery and target lesion treatment, including final residual stenosis <30% and adequate side branch flow.
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Index procedure
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Side Branch Access
기간: Index procedure
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Percentage of subjects with TIMI-3 flow in the side branch and/or need to re-cross the side branch after study device use.
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Index procedure
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Bleeding / Vascular Complications
기간: Hospital discharge
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Percentage of subjects with bleeding or vascular complications.
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Hospital discharge
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Procedure Time
기간: Index procedure
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Duration of the index procedure in minutes
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Index procedure
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Fluoroscopy Time
기간: Index procedure
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Total fluoroscopy duration during index procedure in minutes
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Index procedure
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Contrast Volume
기간: Index procedure
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Total volume of contrast media used during index procedure in milliliters
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Index procedure
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공동 작업자 및 조사자
수사관
- 연구 책임자: Randy E David, PhD, Advanced Bifurcation Systems Inc.
- 연구 의자: Mehran Khorsandi, MD, Advanced Bifurcation Systems Inc.
- 수석 연구원: Adrian Ebner, MD, Sanatorio Italiano, Asunción, Paraguay
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 082825
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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