NCT01247428已完成2 期
A First-In-Human Trial of a New Novel DES (MiStent System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in the Native Coronary Arteries
Micell Technologies7 个研究点 分布在 3 个国家目标入组 30 人开始时间: 2010年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Angiographic In-Stent Late Lumen Loss
研究概览
简要总结
The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.
详细描述
The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions < 20 mm in length in the native coronary arteries with reference vessel diameters between 2.5 mm and 3.5 mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female patients 18-85 years;
- •Stable or unstable angina pectoris, ischemia, or silent ischemia;
- •Planned single, de novo, types A, B1 and B2 coronary lesions;
- •Target lesion located in a native coronary artery;
- •Target lesion vessel diameter 2.5 to 3.5 mm amenable to treatment with a maximum 23 mm long stent;
- •Target lesion >50% diameter stenosis;
- •Patients eligible for percutaneous coronary intervention (PCI);
- •Acceptable candidate for myocardial revascularization surgery;
- •A patient may have one additional critical non-target lesion.
- •The patient will provide written informed consent.
排除标准
- •Female of childbearing potential not on some form of birth control with a confirmed negative pregnancy test at baseline;
- •Recent Q-wave myocardial infarction occurred <72 hours prior to the index procedure. Recent myocardial infarction with elevated levels of cardiac markers;
- •Left ventricular ejection fraction <30%;
- •Patients in cardiogenic shock;
- •Cerebrovascular accident or transient ischemic attack within 6 months;
- •Active GI bleed within three months;
- •Any prior true anaphylactic reaction to contrast agents;
- •Patient receiving/scheduled to receive chemotherapy within 30-days before or after the index procedure;
- •Patient is receiving immunosuppressive therapy or has known life-limiting immunosuppressive/autoimmune disease;
- •Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);
- •Platelet count <100,000 cells/mm³ or >700,000 cells/mm³;
- •White blood cell count <3,000 cells/mm3;
- •Hepatic disease;
- •Heart transplant recipient;
- •Known contraindication to dual antiplatelet therapy;
- •Known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as aspirin, heparin, and all three of the following: clopidogrel bisulfate (Plavix), ticlopidine (Ticlid), and Prasugrel (Effient);
- •Life expectancy <12 months;
- •Any major medical condition that may interfere with the optimal participation of the patient in this study;
- •Patient is currently participating/planning to participate in an investigational drug or another device study prior to completing 12-months follow-up;
- •Target vessel(s) has been treated within 10 mm proximal or distal to target lesion with any type of PCI within a year prior to index procedure;
- •Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter prior to stent placement;
- •Previous coronary intravascular brachytherapy;
- •Planned coronary angioplasty or coronary artery bypass grafting (CABG)in the first 9 months after the index procedure;
- •Prior PCI of a non-target vessel must be at least 30 days prior to study enrollment;
- •The intent to direct stent the target lesion;
- •Angiographic Exclusion Criteria: Assessed prior to stent placement;
- •In-stent restenotic target lesion;
- •More than one lesion requiring treatment in the target vessel;
- •Target vessel diameter <2.5 mm or >3.5 mm;
- •Target lesion not amenable to treatment with a 23 mm long stent;
- •Unprotected coronary artery branch lesion (≥50% DS);
- •Target lesion located in a surgical bypass graft;
- •Total vessel occlusion;
- •Target lesion with ostial location;
- •Target lesion located in a lateral branch bifurcation >2.5mm or requiring lateral branch stenting;
- •Calcified target lesion that anticipates unsuccessful/impracticable predilation;
- •Target vessel excessive tortuosity or proximal angulation (>90 degrees);
- •Thrombus present in target vessel;
- •More than one non-target critical lesion;
- •Non-target lesion to be treated during the index procedure meets any of the following criteria:
- •Within the target vessel;
- •Within a bypass graft;
- •Left main location;
- •Chronic total occlusion;
- •Involves a complex bifurcation.
结局指标
主要结局
Angiographic In-Stent Late Lumen Loss
时间窗: 8 months
In-stent late lumen loss as measured by the angiographic core laboratory as the difference between the post-procedure minimal lumen diameters (MLD) in the treated segment (stented region) minus the MLD in the same region at follow-up.
次要结局
- Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)(240 days)
- Procedural Success(8 hours)
- Clinically-driven Target Lesion Revascularization (TLR) Rates(240 days)
- Target Vessel Failure (TVF)(240 days)
- Device Success(8 hours)
- Total Myocardial Infarction (MI)(240 days)
- Clinically-driven Target Vessel Revascularization (TVR) Rates(240 days)
- Stent Thrombosis(240 days)
- Angiographic Evaluation: In-stent Binary Restenosis(18 months)
- Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered(8 months)
- Lesion Success(8 hours)
- Total Mortality(240 days)
- Target Lesion Failure (TLF)(240 days)
- Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction(8 months)
- IVUS Evaluation: % Neointimal Volume Obstruction(18 months)
- OCT Evaluation: % Stent Strut Uncovered(18 M)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
2 期
Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery DiseaseCoronary Artery DiseaseNCT01294748Micell Technologies184
Unknown
1 期
NeoVas Bioresorbable Coronary Scaffold First-in-Man StudyCoronary Artery DiseaseNCT02195414Lepu Medical Technology (Beijing) Co., Ltd.31
终止
1 期
First-in-human (FIH) Study of DS-1471a in Subjects with Advanced Solid Tumors2024-517984-21-00Daiichi Sankyo Co. Ltd.17
已完成
不适用
The ILLUMINA Study. (ILLUMINA)Peripheral Arterial DiseaseNCT03510676CID - Carbostent & Implantable Devices100
已完成
1 期
A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy PeopleHealthy VolunteersCardiometabolic DiseasesNCT06336005Novo Nordisk A/S56