Intra-patient Randomized Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT Follow up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Number of transversal sections with a percentage (rate of uncovered struts/ total number of struts) > 30 % at 3 months OCT after stent implantation.
研究概览
简要总结
The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent
详细描述
The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent
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
- 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
- •Aged ≥ 18 years
- •Signature of informed consent
- •Patients with angina and a clinical indication for coronary revascularisation with a drug-eluting stent
- •Presence of at least 2 lesions to be revascularised with similar angiographic characteristics
- •Reference lesion diameter with at most a difference of 0.5 mm
- •Maximum difference in lesion length of 10 mm
- •Lesions able to be treated with only 1 stent
排除标准
- •Lesions due to restenosis
- •Lesions in saphenous vein grafts
- •STE-ACS ( ST elevation- Acute Coronary Syndrome)
- •Cardiogenic shock
- •Dual antiplatelet therapy contraindication for> 3 months
- •Follow-up catheterisation contraindicated
- •Chronic kidney failure with creatinine > 2 mg/dL
- •Allergy to iodinated contrast agents
- •Serious complication from vascular access in previous catheterisation
- •Ineligible for evaluation via optical coherence tomography
- •Lesion located <5 mm from aorto-ostial junction
- •Severe proximal angulation >90º
- •Bifurcation lesion requiring a strategy with two stents
- •Angiographic characteristics that promote stent malposition
- •Aneurysm or coronary artery ectasia
- •Presence of a thrombus classed as TIMI (Thrombolysis In Myocardial Infarction )2 flow or higher
- •Severe calcification, in particular in cases of calcium spike
- •Severe lesion angulation
- •Inability to do reliable follow-up, in the investigator's opinion
研究组 & 干预措施
Coroflex® ISAR Drug-eluting stent in first lesion
Patients with Coroflex® ISAR Drug-eluting stent in the first lesion
干预措施: Coroflex® ISAR Drug-eluting stent (Device)
Ultimaster® Drug-eluting stent in first lesion
Patients with Ultimaster® Drug-eluting stent in first lesion
干预措施: Ultimaster® Drug-eluting stent (Device)
Coroflex® ISAR Drug-eluting stent in second lesion
Patients with with Ultimaster® Drug-eluting stent in first lesion
干预措施: Coroflex® ISAR Drug-eluting stent (Device)
Ultimaster® Drug-eluting stent in second lesion
Patients with Coroflex® ISAR Drug-eluting stent in the first lesion
干预措施: Ultimaster® Drug-eluting stent (Device)
结局指标
主要结局
Number of transversal sections with a percentage (rate of uncovered struts/ total number of struts) > 30 % at 3 months OCT after stent implantation.
时间窗: 3 months
Percentage of covered struts at 3 months OCT after stent implantation.
时间窗: 3 months
Percentage of early coating on the struts of the Coroflex® ISAR Drug-eluting stent versus Ultimaster® - Drug eluting stent at 3 months OCT after stent implantation.
时间窗: 3 months
Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation.
时间窗: 3 months
Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation.
时间窗: 3 months
次要结局
- Percentage of covered struts, at 1 month, 2 months and 3 months OCT after stent implantation.(1 month and 2 months and 3 months)
- MACE (Major Adverse Cardiac Events) at 30 days, 3 months, 6 months and 12 months.(30 days and 3 months and 6 months and 12 months)
- Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation.(1 month and 2 months and 3 months)
- Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation.(1 month and 2 months and 3 months)
- Percentage of struts malapposition> 260 µm at 1 month and 3 months OCT after stent implantation.(1 month and 2 months and 3 months)
- Percentage of stents with any malapposition strut > 260 µm at 1 month and 3 months OCT after stent implantation.(1 month and 2 months and 3 months)
- Healing Score at 1 month and 3 months OCT after stent implantation .(1 month and 2 months and 3 months)
- Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation.(1 month and 2 months and 3 months)
- Mean thickness of struts tissue coverage at 1 month, 2 months and 3 months OCT after stent implantation.(1 month and 2 months and 3 months)
- Target lesion revascularization and target vessel revascularization at 30 days, 3 months, 6 months and 12 months OCT after stent implantation .(30 days and 3 months and 6 months and 12 months)