Fractional Flow Reserve - Guided Elective Coronary Angioplasty Using Paclitaxel - Eluting Balloons With Provisional Stent Implantation: A Phase 4 Feasibility Study With 6-Month Follow-up by Optical Coherence Tomography
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Late lumen loss
研究概览
简要总结
We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions.
详细描述
Restenosis rates after plain-old balloon angioplasty (POBA) are with 30-50 % very high. Therefore, this interventional concept is of limited use today. However, dual antiplatelet therapy (DAPT) is not necessary after POBA. Contrary, 3rd generation drug-eluting stents (DES) proved to be very effective showing delayed restenosis only in 5-15%, but require DAPT for at least 6 months. Drug-eluting balloons (DEB) might be a promising trade-off between POBA and DES, since they effectively inhibit neointimal proliferation despite minimal duration of DAPT. However, there is still very limited data on this interventional strategy. Thus, we aimed to investigate feasibility of fractional flow reserve (FFR) - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions, evaluating the 6-month outcomes by angiography and optical coherence tomography (OCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for elective PCI according to the guidelines of European Society of Cardiology, American Heart Association and American College of Cardiology
- •Age > 18 years, written consent
- •Native de novo coronary lesion suitable for angioplasty and OCT imaging
排除标准
- •Pregnancy and breast feeding mother
- •Co-morbidity with an estimated life expectancy of < 50 % at 1 year
- •Scheduled major surgery in the next 6 months
- •Not able to give informed written consent or non-compliance
- •Participation in other PCI trial
- •Acute coronary syndromes and cardiogenic shock
- •Known allergy to aspirin, thienopyridines or against taxol derivates
- •Culprit lesion within the proximal 10 mm of the right or left coronary artery
- •Saphenous vein grafts
- •Estimated lesion length > 30 mm
结局指标
主要结局
Late lumen loss
时间窗: 6 months
Late lumen loss (LLL, expressed in mm) measured within the treated segment by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter (MLD) at the end of the interventional procedure and MLD at 6-month follow-up
次要结局
- Vessel remodeling assessed by optical coherence tomography(6 months)
- Net lumen gain(6 months)
- Need for revascularization of the treated vessel segment(6 months)
研究者
Tudor C. Poerner, MD
PD Dr. med. Tudor C. Poerner
University of Jena