跳至主要内容
临床试验/NCT02298413
NCT02298413Unknown不适用

Clinical Study on Absorb Polylactic, Reabsorbable Coronary Scaffold (RAI)

Ospedale Santa Croce-Carle Cuneo1 个研究点 分布在 1 个国家目标入组 1,520 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,520
试验地点
1
主要终点
Scaffold thrombosis

研究概览

简要总结

The investigators aim at evaluating the long-term (5-year) clinical outcome following Absorb BVS implantation in a real world, all-comers population of consecutive patients, as treated according to the indications, techniques and protocols used in the participating institutions.

详细描述

Long-term data after implantation of coronary BVS is scarce, especially in subgroups of patients with diabetes or chronic kidney disease, and in those with complex coronary lesions and/or multivessel disease.

Although the use of BVS is very promising in younger patients with one or more of the above characteristics, evidence of benefit is not available.

The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists who are interested in assessing the results of their interventional practice with BVS, by sharing data.

The BVS-RAI Registry has been created in joint-venture with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri Sud", and is not recipient of funding or benefits originating from the BVS manufacturer or seller. BVS devices are regularly purchased by the participating centres.

Each participating centre is willing to input data of all consecutive patients treated with BVS, with a minimum of 50, and to report on follow-up for at least 5 years. Patient recruitment is not directed per protocol, nor is it rewarded. Patients who give informed consent are included in the BVS-RAI Registry after BVS implant has been performed following the indications, techniques and protocols used in each of the participating institutions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Successful implantation of 1 or more coronary BVS
  • Age <75 years
  • Patient's informed consent

排除标准

  • 未提供

结局指标

主要结局

Scaffold thrombosis

时间窗: 1 year

acute, subacute, late and very late

Target lesion revascularization

时间窗: 1 year

ischemia or angiographic-driven

次要结局

  • MACE(5 year)

研究者

发起方
Ospedale Santa Croce-Carle Cuneo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Giuseppe Steffenino

MD

Ospedale Santa Croce-Carle Cuneo

研究点 (1)

Loading locations...

相似试验