Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Minimal in-scaffold lumen area (mm2) as assessed by OCT
研究概览
简要总结
Fully Bioresorbable Vascular Scaffolds (BVS) have been introduced with the objective to preserve native vessel geometry, allow for adaptive vessel remodeling with late lumen gain, restore physiological vasomotion, and avoid late adverse events including restenosis and scaffold thrombosis. Although randomized clinical trials in low risk patients to date suggest non-inferiority in terms of safety and efficacy compared with metallic DES, several reports have raised concerns regarding the scaffold thrombosis highlighting the importance of technical considerations regarding lesion preparation and scaffold expansion. OCT offers the opportunity to plan the procedure and optimize the implantation of BVS.
The hypothesis of the present study is that a strategy of OCT-guided PCI using BVS is superior to angiography-guided PCI (e.g. by selecting scaffold dimension on the basis of a pre-procedural OCT and applying corrective measures in case of suboptimal treatment result as indicated by OCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years.
- •Patient provides signed written informed consent before any study-specific procedure.
- •De novo native coronary artery disease with lesions that have a distal and proximal reference vessel diameter in the range between 2.25mm and 3.8mm.
- •Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated at baseline with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
- •Full revascularization of all lesions should be achievable (staged PCI not recommended)
- •Elective or ad hoc PCI, stable angina and acute coronary syndrome (NSTE-ACS and STEMI).
- •Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery and evidence of ischemia.
排除标准
- •Subjects with left main lesion.
- •Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- •Subjects with restenosis or stent thrombosis in the target vessel.
- •Severely calcified lesions requiring rotablation.
- •Bifurcation with sidebranch >2.5mm or any sidebranch that possibly requires treatment with angulation >70°
- •Severe angulation (>90°) or excessive tortuosity (>two 45° angles)
- •Known renal insufficiency (serum creatinine clearance <45ml/min or receiving dialysis).
- •Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
- •Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
- •Life expectancy less than 1 year.
- •Indication for oral anticoagulation
- •Known allergy against protocol-required medications including ASA, prasugrel, ticagrelor, clopidogrel, heparin, iodinated contrast (the latter in case it cannot be adequately premedicated)
- •History of bleeding diathesis or known coagulopathy.
- •Planned surgery within the next 6 months
结局指标
主要结局
Minimal in-scaffold lumen area (mm2) as assessed by OCT
时间窗: 6 months
The lumen area is assessed by OCT
次要结局
- angiographic endpoints(6 months)
- Number of adverse events(6 months)
- OCT imaging endpoints(end of procedure)
- Additional OCT imaging endpoints(6 months)