A pilot study to evaluate the efficacy and safety of different bindarit dosages in preventing stent restenosis - ND

• Conditions: PATIENTS WITH BARE METAL STENT IMPLANT; MedDRA version: 9.1Level: HLGTClassification code 10003216Term: Arteriosclerosis, stenosis, vascular insufficiency and necrosis

• Registration Number: EUCTR2008-004921-40-IT
• Lead Sponsor: ANGELINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main study objective is to assess the efficacy of different bindarit dosages compared to placebo in preventing restenosis, in patients underwent to coronary stenting and using the Vision (Abbott) bare-metal stent.;Secondary Objective: Secondary endpoints will be the assessment of the safety profile of the two bindarit dosages compared to placebo;Primary end point(s): The primary endpoint will be the in-segment late loss (in-stent and 5 mm proximally and distally to the stent) evaluated at angiography performed at 6 months from the index procedure.