Prospective Randomized Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions / BABILON Study (Paclitaxel-Coated Balloon in Bifurcated Lesions)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 190
- 试验地点
- 18
- 主要终点
- Late Lumen Loss (LLL)
研究概览
简要总结
This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch.
详细描述
The bifurcated coronary lesions are still a challenge for interventional cardiologists, since there is no suitable technique or strategy to manage such lesions.
This multicenter randomized prospective trial in bifurcated coronary lesions will compare the new technology of the paclitaxel-eluting balloon with the until now "gold standard" technique of the "provisional stenting" with the paclitaxel DES in the main branch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable angina (1-3) or unstable angina (1-3 A-C) or documented silent ischemia
- •Patients with mental and logistic conditions for the follow-up
- •Patients should accept an angiographic follow-up at 9 months, a clinical follow-up at 3 years and sign the consent
- •De-novo lesions in the bifurcations of DA/Diag either CX/OM or CD/DP with diameters in the main vessel of 2,5 to 3,8/ 2 to 3,5 and lengths < 22 mm
- •The left main lesions in bifurcation are also accepted but with another independent randomization list (specify at randomization)
- •The diameter of the stenoses should be >50% in any branch with documented ischemia or more than 70% in absence of an ischemia test
- •Single vessel or multivessel disease
- •In case of a PTCA of more than one lesion, the non included lesion should be treated previously to the included lesion
排除标准
- •Patients with STEMI < 72 hours
- •Patients with congestive heart failure or NYHA IV, shock or severe valvular heart disease
- •Patients with short life expectancy, or with problems for platelet antiaggregation
- •Patients in treatment with hyperthyroidism, in treatment with immunosuppression or anticoagulants, or with alcohol or drug addiction
- •Patients included in other trials
- •Patients with a stroke 6 months before
- •Patients with a surgery one week before
- •Severe renal failure calculated as GF < 30 ml/min "Cockcroft Gault"
- •Women of childbearing age, with probability to become pregnant during the first year of follow-up
- •Evidence of important thrombus within the vessel to treat
- •Patients with another stent previously implanted at ≤ 15 mm from the current lesion of the study
- •Lesions affecting bypass
- •Chronic occlusions to treat
- •Restenosis in-stent or of a segment in 4 mm close to the target lesion
- •Severe calcification not totally dilatable with the balloon
结局指标
主要结局
Late Lumen Loss (LLL)
时间窗: Late angiographic follow-up (9 months)
Assessment of the difference between both groups regarding the Late Lumen Loss (LLL) in main vessel and side branch, measured at late angiographic follow-up at 9 months
Restenosis
时间窗: Late angiographic follow-up (9 months)
Assessment of the difference between both groups regarding the Restenosis in both branches (proximal part of the main vessel, distal part of the main vessel and side branch), measured at late angiographic follow-up at 9 months
次要结局
- Thrombosis rate(Late angiographic follow-up (9 months))
- Target Lesion Revascularization (TLR)(Late angiographic follow-up (9 months))
- Major Adverse Cardiac Events (MACE)(Late angiographic follow-up (9 months))