EUCTR2008-004921-40-IT
Active, Not Recruiting
N/A
A pilot study to evaluate the efficacy and safety of different bindarit dosages in preventing stent restenosis - ND
ANGELINI0 sitesSeptember 19, 2008
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- PATIENTS WITH BARE METAL STENT IMPLANT
- Sponsor
- ANGELINI
- Status
- Active, Not Recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not Yet Recruiting
Phase 2
Effectiveness of Low carb products in mitigating blood sugar spikes in patients with Type 2 Diabetes Mellitus.CTRI/2023/05/053173Bajo Foods Pvt Ltd
Not Yet Recruiting
N/A
Effect of low carbohydrate food products on diabeticsCTRI/2022/10/046931Bajo Foods Pvt Ltd
Active, Not Recruiting
Phase 1
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)Therapeutic area: Not possible to specifyEUCTR2018-001659-11-ESCOSMETIC SURGERY BCN SLP15
Completed
Phase 2
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
Not Yet Recruiting
Phase 2
Study to assess hair growthCTRI/2024/03/064879AVT Natural Products Limited