DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 10
- 主要终点
- Percentage of vessels with a positive response to Ach, defined as >4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol/L).
研究概览
简要总结
Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm
详细描述
Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm
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
- 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
- •Patients who meet all of the following conditions are included.
- •Patients aged ≥ 18 years and;
- •Patients with chronic coronary syndrome, acute coronary syndrome without ST segment elevation or acute coronary syndrome with elevation ST segment in non-culprit lesions 48 hours after the event and;
- •Patients with de novo lesions in vessels ≥ 3.5 mm without calcification significant no visible thrombus and;
- •Patients who have been informed of the characteristics of the study and have provided their written informed consent.
排除标准
- •Patients who meet at least one of the following conditions are excluded:
- •Patients with any contraindication for the administration of acetylcholine (ACh) or nitroglycerin (NTG).
- •Patients with a history of coronary vasospasm or spontaneous dissection of the coronary artery.
- •Patients with significant medical, surgical or psychiatric condition that would affect the safety of the subject or influence the outcome of the study according to the doctor's opinion.
- •Patients who received a combination of DES and DCB in the same vessel
- •Patients with glomerular filtration rate <30 ml/min/ 1.73 m2
- •Patients with body mass index >35 (may affect the evaluation qualitative diameter of the coronary artery).
- •Patients with symptomatic congestive heart failure.
- •Patients with significant autoimmune inflammatory conditions and patients taking immunomodulatory medications (including methotrexate, cyclosporine, steroids).
- •Patients with heart transplant.
- •Patients with anemia (Hb <12 g/dL in men and <10 g/dL in women).
- •Patients, women of childbearing age with a positive pregnancy test.
- •Pregnant female patients.
- •Patients included in other clinical trials with active follow-up.
研究组 & 干预措施
Drug Eluting Stent (DES)
Drug Eluting Stent (DES)
干预措施: Drug Eluting Stent (DES) (Device)
Drug Coated Balloon (DCB)
Drug Coated Balloon (DCB)
干预措施: Drug Coated Balloon (DCB) (Device)
结局指标
主要结局
Percentage of vessels with a positive response to Ach, defined as >4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol/L).
时间窗: 8 months
Percentage of vessels with a positive response to Ach, defined as \>4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol/L).
次要结局
- Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography(8 months)
- Comparison of percentage of angiographic restenosis by quantitative coronary(8 months)
- Comparison of the minimum luminal area of the treated segment by optical coronary tomography(8 months)
- Percentage of of strut coverage by OCT(Optical Coherence Tomography) in the DES group(8 months)
- Percentage of vessels with normal vascular architecture with correct definition of intima and media by optical coherence tomography in the drug-coated balloon group at 8 months(8 months)