Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System for Bifurcation Lesions (First-in-Human, Feasibility Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Procedure Success
研究概览
简要总结
This first in human feasibility study is designed to evaluate the feasibility MD-SBA DES in subjects undergoing percutaneous coronary intervention (PCI) to treat bifurcation lesions.
详细描述
This is a prospective, single-arm, single-center initial feasibility 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with coronary bifurcation lesions
Patients undergoing PCI to treat a bifurcation lesion
干预措施: MD-SBA DES System (Device)
结局指标
主要结局
Procedure Success
时间窗: Periprocedural
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).
次要结局
- Side Branch Access(Index procedure)
- MACE(30-days, 6-months, 1-year, 2-years, and 3-years post index procedure)
- TVF(30-days, 6-months, 1-year, 2-years, and 3-years post index procedure)
- Target Lesion Revascularization of the Side Branch(30-days, 6-months, 1-year, 2-years, and 3-years post index procedure)
- Stent thrombosis(6-months, 1-year, 2-years, and 3-years post index procedure)
- Acute Success(Index procedure)
- Bleeding / Vascular Complications(Hospital discharge)
- Procedure Time(Index procedure)
- Fluoroscopy Time(Index procedure)
- Contrast Volume(Index procedure)