Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Endothelial stent coverage
研究概览
简要总结
The aim of this study is a comparative evaluation of re-endothelailisation of the Integrity Resolute zotarolimus eluting stent (Medtronic) and of the Promus Element erolimus eluting stent (Boston Scientific), in patients with diabetes.
We plan to compare endothelial coverage and neointimal proliferation using OCT and compare this data to published results from conventional stents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known to have diabetes
- •Scheduled for percutaneous coronary intervention (PCI) with a stenosis suitable for DES implantation and OCT imaging
- •Reference vessel diameter over 2.5mm by operator assessment.
- •Able to understand and sign the written Informed Consent Form.
- •Able and willing to follow the Protocol requirements.
排除标准
- •Inability to consent
- •Cardiogenic shock
- •Planned use of a bare metal stent
- •LMS coronary artery disease
- •Congestive cardiac failure or low ejection fraction (LVEF <35%)
- •Lesions unsuitable for OCT
- •Total length of stented lesion greater than 55mm (total combination of stent lengths)
- •Age less than 18 years or age greater than 80 years
- •Planned surgical procedure ≤ 12 months post PCI procedure
- •Patient demonstrates evidence of thrombocytopenia (platelet count < 100,000/mm3)
- •Patients with contraindications to ASA, clopidogrel, or prasogrel
- •Patient is currently on warfarin, or possibility of treatment with warfarin during the following 12 months post index procedure
- •Allergy to contrast
- •Patients enrolled in another active clinical trial.
- •Potential for non-compliance towards the requirements in the study protocol.
- •Serious known concomitant disease with a life expectancy of less than one year
- •Follow-up impossible (no fixed abode, etc)
- •Patients with renal impairment (Creatinine >200mmol/L)
- •Subjects of childbearing potential
研究组 & 干预措施
Resolute Integrity Stent
Patients will be randomised in a 1:1 ratio to receive two different types of DES
干预措施: Optical coherence tomography (Device)
Promus Stent
Patients will be randomised in a 1:1 ratio to receive two different types of DES
干预措施: Optical coherence tomography (Device)
结局指标
主要结局
Endothelial stent coverage
时间窗: 6 month
Endothelial coverage expressed as % of struts without coverage as measured by OCT
次要结局
- MACE(6 months)
- Neointimal hyperplasia(6 month)
研究者
Anthony Mathur
Professor
Barts & The London NHS Trust