E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PATIENTS WITH BARE METAL STENT IMPLANT |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10003216 |
E.1.2 | Term | Arteriosclerosis, stenosis, vascular insufficiency and necrosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints will be the assessment of the safety profile of the two bindarit dosages compared to placebo |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 16 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |