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临床试验/NCT01297257
NCT01297257已完成不适用

DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting

Medtronic Vascular1 个研究点 分布在 1 个国家目标入组 7,845 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7,845
试验地点
1
主要终点
Delivery Success

研究概览

简要总结

The primary objective of the DELIVER Study is to assess the deliverability of the Resolute Integrity Stent as primary stent or as a secondary cross-over stent following delivery failure of another stent type in real world patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Minimum legal age (18)
  • Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines
  • Patient has consented to participate and authorized in writing the collection and release of medical information

排除标准

  • Pregnancy
  • Participating in another study that interferes with study endpoints
  • Untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, zotarolimus or similar drugs or contrast media
  • Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated

结局指标

主要结局

Delivery Success

时间窗: stent implantation until hospital discharge (average 1-3 days)

The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.

次要结局

  • In-hospital MACE (Major Adverse Cardiac Event)(stent implantation until hospital discharge (average 1-3 days))

研究者

发起方
Medtronic Vascular
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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