Numen Stent Assessment Using OCT Technique in a Single Center Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The primary endpoint is the assessment of the development of neointimal hyperplasia by OCT in the stented segment at 6-month follow-up.
研究概览
简要总结
This is a prospective single centre Study designed to assess by OCT the effect of NUMEN cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or ACS (except STEMI).
A total of 60 consecutive patients will be enrolled in the study. Patients with de novo native coronary artery lesions >10mm and <24mm in length and >2.50mm to <3.50mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation. After stent deployment an OCT imaging will be performed within the treated segment. Patients will be followed at 30 days, 6 months and 12 months post-procedure, with all patients having repeat angiography and OCT at 6 months.
It is anticipated that the total length of the study will be 18 months: 6 months to complete patient enrolment and 12 months for follow-up.
详细描述
OBJECTIVES
The main objective of this study is to assess the long term influence of NUMEN cobalt-chromium balloon-expandable coronary stent on neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or Acute Coronary Syndrom (ACS) - except STEMI.
ENDPOINTS
The primary endpoint is the assessment of the development of neointimal hyperplasia by OCT in the stented segment at 6-month follow-up.
Breakdown of secondary endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must meet all of the following criteria:
- •The patient must be > 18 years of age;
- •Diagnosis of stable angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) or ACS (except STEMI).
- •Treatment of de novo lesion in a major coronary artery in patients with single or two-vessel disease.
- •Target vessel diameter at the lesion site is >2.50mm and <3.50mm in diameter (QCA);
- •Target lesion is >10mm and <24mm in length (visual estimate);
- •Target lesion stenosis is >50% and <100% (visual estimate);
- •Acceptable candidate for coronary artery bypass surgery (CABG);
- •Patient is willing to comply with the specified follow-up evaluation;
- •Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee.
排除标准
- •Patients will be excluded if any of the following conditions apply:
- •multiple lesions in the same vessel;
- •ACS with STEMI (within 48 hours)
- •vessel size < 2.50mm and >3.50mm reference diameter;
- •length of the lesion > 24 mm;
- •unprotected left main coronary disease with >50% stenosis;
- •have an ostial target lesion;
- •have a target lesion in a venous graft;
- •angiographic evidence of thrombus within target lesion;
- •calcified lesion which cannot be successfully predilated;
- •Documented left ventricular ejection fraction >25%;
- •Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
- •Pretreatment with devices other than balloon angioplasty;
- •Prior stent within 5mm of target lesion;
- •Recipient of heart transplant;
- •Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, cobalt, chromium, or contrast agent (that cannot be managed medically)
- •Recent (6 months) cerebrovascular accidents or intracranial hemorrage
- •Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
- •Currently participating in an investigational drug or another medical device study;
- •In the investigator's opinion, the lesion is not suitable for stenting.
- •Life expectancy ≤ 12 months
结局指标
主要结局
The primary endpoint is the assessment of the development of neointimal hyperplasia by OCT in the stented segment at 6-month follow-up.
时间窗: 6 months
次要结局
- Endothelialization of the stent internal wall by OCT at 6 months ; (MACE) at 30 days, 6 and 12 months Angiographic binary restenosis at 6m Target vessel failure at 6m. Device, lesion, procedure success. Thrombosis(12 months)