Patients with ischemic hear disease with up to two de novo native coronary artery lesions. MedDRA version: 8.1 Level: LLT Classification code 10011078 Term: Coronary artery disease
Conditions
Interventions
Trade Name: Genous Bio-engineered Stent
Product Name: Genous Bio-engineered stent
Product Code: NA
Pharmaceutical Form: Implant
Sponsors
Orbus International BV
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 700,000 cells/mm3 or a WBC of 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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). ;Secondary Objective: 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. ;Primary end point(s): The primary endpoint of this study is in-stent late loss at 6 months by Quantitative Coronary Angiography (QCA). | — |
Countries
Netherlands
Outcome results
None listed