A Randomized Prospective Multicenter Trial to Compare Vascular Healing and Vasodilation at 3 Months After Deployment of PRO-Kinetic Drug-eluting Stent and Endeavor Resolute Zotarolimus-eluting Stent in Patients With Acute Coronary Syndromes by Means of Optical Coherence Tomography and Coronary Flow Reserve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Uncovered stent struts
研究概览
简要总结
The purpose of this study is to compare vascular healing of the stented segment after deployment of new PRO-Kinetic drug eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.
详细描述
Objective
The aim of the trial is to compare vascular healing and vasodilation at 3 months after deployment of PRO-Kinetic drug-eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndrome.
Design: A prospective, randomized and controlled study comparing coronary flow reserve and coverage of the PRO-Kinetic DES and Endeavor Resolute DES implanted in acute coronary syndrome. OCT and CFR measurement at 3 months. Clinical follow up is scheduled at 3, 6 and 12 months.
Primary endpoint: Uncovered stent struts and CFR at 3 months after stent implantation.
Secondary clinical endpoints: MACE and stent thrombosis.
Enrollment: 40 patients (20 receiving PRO-Kinetic DES and 20 receiving Endeavor Resolute DES).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •STEMI or NSTEMI or unstable angina
- •Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics committee or Institutional Review Board.
- •Single de novo or non-stented restenosis lesion of LAD
- •Patients with two-vessel disease may have undergone successful treatment of the non-target vessel with approved devices up to and including the index procedure but must be treated prior to the index target vessel treatment.
- •Target lesion (maximum 20 mm length by visual estimate) to be covered by a single stent of maximum 23mm length.
- •Reference vessel diameter must be >2.5mm and <4.0mm by visual estimate.
- •The vessel diameter should be measured after pre-dilation procedure and after intracoronary nitroglycerin if vasospasm is suspected.
- •Target lesion >50% and <100% stenosed by visual estimate.
排除标准
- •Pre-existing diagnosis of diabetes irrespective of its type.
- •Impaired renal function (serum creatinine >177micromol/l) or on dialysis
- •Platelet count < 10 e5 cells/mm3
- •Patient has a history of bleeding diathesis or coagulopathy or patients in whom antiplatelet and and/or anticoagulation therapy is contraindicated.
- •Patient has received organ transplant or is on a waiting list for any organ transplant.
- •Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/prasugrel, stainless steel alloy, or contrast agent that cannot be adequately pre-medicated.
- •Patient presents with cardiogenic shock.
- •Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study.
- •Currently participating in another investigational drug or device study.
- •Unprotected left main disease.
- •Ostial target lesions.
- •Chronic total occlusion.
- •Calcified target lesions that cannot be adequately pre-dilated.
- •Target lesion has excessive tortuosity unsuitable for stent delivery and deployment.
- •Target lesion involving bifurcation with a side branch larger than 2.0mm in diameter.
- •A >30% stenosis proximal or distal to the target lesion that cannot be covered with the same stent.
结局指标
主要结局
Uncovered stent struts
时间窗: 3 months
Percentage of uncovered stent struts per stent by OCT
Coronary flow reserve
时间窗: 3 months
Coronary flow reserve by transthoracic echocardiography.
次要结局
- MACE and target vessel stent thrombosis(12 months)
研究者
Tuomas Kiviniemi
MD, PhD
University of Turku