E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with ischemic hear disease with up to two de novo native coronary artery lesions. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011078 |
E.1.2 | Term | Coronary artery disease |
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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 primary objective of this study is to evaluate the safety and effectiveness of the Genous Bio-engineered R stent in conjunction with optimal statin therapy (80mg of atorvastatin), in the treatment of elective patients with up to two de novo native coronary artery lesions.
Primary Endpoint The primary endpoint of this study is in-stent late loss at 6 months by Quantitative Coronary Angiography (QCA).
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E.2.2 | Secondary objectives of the trial |
Secondary Endpoints The following secondary endpoints will be assessed: • Angiographic success • Procedure success • Angiographic and/or clinical stent thrombosis • In-stent late loss at 18 months • Binary restenosis rate at 6 and 18 months • In-segment late loss at 6 and 18 months • Volumetric assessment (derived from QCA parameters) at 6 and 18 months • Circulating endothelial progenitor cell (EPC) count at screening, index procedure and at 30 days • Target Vessel Failure (TVF) at 30 days, 6, 12 and 18 months and at 2, 3, 4 and 5 years • Major adverse cardiac events (MACE) at 30 days, 6, 12 and 18 months and at 2, 3, 4 and 5 years • Clinically-driven Target Lesion Revascularization (TLR) free rate at 30 days, 6, 12 and 18 months and at 2, 3, 4 and 5 years • Protocol related serious adverse events (SAEs) up to 5 years • Change in human anti-murine antibody (HAMA) plasma levels at 1 and 6 months follow-up as compared to baseline.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 18 to 85 years of age; 2. Symptomatic ischemic heart disease (CCS class 1–4, Braunwald class IB, IC, and/or objective evidence of myocardial ischemia); 3. Treatment of 1 or 2 de novo lesions; 4. Target lesion(s) is(are) located in a native coronary artery, which can be covered by one single stent of maximum 33 mm; The coronary artery lesion should be 27 mm in length (a margin of 3mm proximal and 3mm distal is recommended) and should be entirely covered by one single Genous Bio-engineered R stentTM . If predilation of the lesion is visually deemed necessary it should be performed prior to measuring the length of the lesion. 5. Reference vessel diameter 2.5 and 3.75 mm by visual estimate; 6. Acceptable candidate for coronary artery bypass surgery (CABG); 7. Target lesion stenosis is >50% and <100% (minimum TIMI flow I at the time of the PCI procedure) (visual estimate); 8. The patient is willing to comply with the specified follow-up evaluation; 9. The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Ethics Committee (EC).
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E.4 | Principal exclusion criteria |
General exclusion criteria: 1. Women who are pregnant or women of childbearing potential who do not use adequate contraception; 2. A Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes or Troponin levels are less than twice the Upper Normal Limit; 3. Impaired renal function (creatinine > 3.0 mg/dl or 265 µmol/l); 4. Any patient who has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC of < 3,000 cells/mm3; 5. Documented or suspected liver disease (including laboratory evidence of hepatitis); 6. Recipient of heart transplant; 7. Any patient who previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-mouse Antibodies (HAMA); 8. Patient with a life expectancy less than the follow-up period (5 years); 9. Known allergies to aspirin, clopidogrel bisulphate (Plavix) and ticlopidine (Ticlid), heparin, or stainless steel; 10. Known side-effects (clinically demonstrated by biological tests, elevated CK and liver assessments) to statins and previous attempts to treat side-effects were unsuccessful; 11. Any significant medical condition which in the Investigator’s opinion may interfere with the patient’s optimal participation in the study; 12. Currently participating in an investigational drug or another device study that has not completed the primary endpoint, or subject to inclusion in another investigational drug or another device study during follow-up of this study; 13. Patients currently undergoing chemotherapy or immunosuppressant therapy; 14. Patients with known malignancy(ies).
Angiographic exclusion criteria: 15. Unprotected left main coronary artery disease with 50% stenosis; 16. Ostial target lesion; 17. Totally occluded target vessel (TIMI flow 0); 18. Target lesion has excessive tortuousity unsuitable for stent delivery and deployment; 19. Target lesion involves bifurcation class D & type G including a side branch 2.5mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require stenting of diseased side branch; 20. Angiographic evidence of thrombus in the target vessel; 21. A significant (> 50%) stenosis proximal or distal to the target lesion; 22. Impaired runoff in the treatment vessel with diffuse distal disease; 23. Ejection fraction 30%; 24. Pre-treatment with devices other than balloon angioplasty, although direct stenting is allowed; 25. Prior stent within 5mm of target lesion; 26. Intervention of another lesion within 6 months before or within the scheduled angiographic follow-up of the index procedure.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is in-stent late loss at 6 months by Quantitative Coronary Angiography (QCA). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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 | Yes |
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
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After the five year follow up contact. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |