EUCTR2008-004921-40-IT进行中（未招募）不适用
A pilot study to evaluate the efficacy and safety of different bindarit dosages in preventing stent restenosis - ND
ANGELINI0 个研究点开始时间: 2008年9月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a. Male and female patients with no limitation of race, > 18 years of age (or minimum age as required by local regulations). Female patients of childbearing potential, required to have a negative pregnancy test (see Section 9.1.2) and use a birth control method. b. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III), or patients with documented silent ischemia. c. Maximum of two de novo lesions (>70% stenosis) per patients, to be treated with no other planned procedure within six months from the index intervention. d. Each lesion should require a single stent not longer than 28 mm and with a diameter of 2.5 mm or larger. In case additional stents are needed, the operator will be allowed to implant them in order to treat a suboptimal result such as residual edge stenosis or dissection. Additional stents should be implanted with minimal overlap. Multiple stenting should not be allowed as intention to treat strategy due to the specific inclusion criteria which has been set. e. Patients eligible for the placement of the Vision (Abbott) bare metal stent. f. The patient willing and able to cooperate with the protocol procedures, particularly attending the scheduled visits. g. Patients legally able to give written informed consent to the trial. h. A written informed consent to the trial signed and dated by the patient is available.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such the study medication, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media, or with a positive history for drug allergy. b. Lesions in venous or arterial grafts. c. Total occlusions. d. In-stent restenosis. e. Unprotected Left Main lesions. f. Acute myocardial infarction (ST elevation and/or Non ST Elevation ) in the 48 hours prior to the procedure. g. Women with known pregnancy or who are lactating. h. Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated. i. Current medical condition with a life expectancy of less than 24 months. j. The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this trial. k. Patients under the influence of alcohol or narcotics. l. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.
研究者
相似试验
尚未招募
2 期
Effectiveness of Low carb products in mitigating blood sugar spikes in patients with Type 2 Diabetes Mellitus.CTRI/2023/05/053173Bajo Foods Pvt Ltd
尚未招募
不适用
Effect of low carbohydrate food products on diabeticsCTRI/2022/10/046931Bajo Foods Pvt Ltd
进行中（未招募）
1 期
Study to evaluate the safety and efficacy of Belkyra™ in the fat located in the hypogastric zone.Subjects with fat located in the treatment area (hypogastrium)EUCTR2018-001659-11-ESCOSMETIC SURGERY BCN SLP15
已完成
2 期
A Pilot study to evaluate the safety and efficacy of Gunmakudori Mezhugu in the management of Polycystic ovarian syndrome (PCOS).CTRI/2022/03/041489Central Council for Research in Siddha34
尚未招募
2 期
Study to assess hair growthCTRI/2024/03/064879AVT Natural Products Limited