Patients with symptomatic ischemic heart disease expressing one or two de novo native coronary artery lesions MedDRA version: 9.1 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
Trade Name: Xience V, stent coated with everolimus
Product Name: Xience
Sponsors
OrbusNeich Medical BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Currently receiving statin therapy for at least 2 weeks prior to the index procedure; 2. 18 to 85 years of age; 3. Symptomatic ischemic heart disease (CCS class 1–4, Braunwald class IB, IC, and/or objective evidence of myocardial ischemia); 4. Single de novo lesions; Patients with an additional lesion in another vessel can be included, however, the vasomotion study is to be performed on only one lesion which is identified by the investigator, prior to randomization, as the one which is most suitable for vasomotion study. 5. Target lesion is located in a native coronary artery, which can be covered by one single; 6. Reference vessel diameter ? 2.5 and ? 4.0 mm by visual estimate; 7. Acceptable candidate for coronary artery bypass surgery (CABG); 8. Target lesion stenosis is >50% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. Uncontrolled hypertension or currently treated with three or more hypertensive medications. Patients unable to discontinue beta blockers, calcium antagonists, nitrates, ACE inhibitors or angiotensin II inhibitors for 48 hours prior to the scheduled 6 month angiographic follow-up should not be included. 4. Impaired renal function (creatinine > 3.0 mg/dl or 265 µmol/l); 5. Any patient who has a platelet count 700,000 cells/mm3 or a WBC of 50%) stenosis proximal or distal to the target lesion; 23. Impaired runoff in the treatment vessel with diffuse distal disease; 24. Left Ventricular ejection fraction ? 30%; Other exclusion criteria: 25. Pre-treatment with devices other than balloon angioplasty, although direct stenting is allowed; 26. Prior stent within 5mm of target lesion; 27. Intervention of another lesion within 6 months prior to or after the index procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess endothelial-dependent vasomotion after stenting with Genous and drug-eluting stents (Xience V) at 6 month follow-up. The primary endpoint of this study is mean coronary segment diameter change from baseline after maximal endothelium-dependent vasomotion at 6 months post-procedure.;Primary end point(s): The primary endpoint of this study is mean coronary segment diameter change from baseline after maximal endothelium-dependent vasomotion at 6 months post-procedure.;Secondary Objective: The following secondary endpoints will be assessed: • Mean coronary segment diameter change from baseline after maximal endothelium-independent vasodilation at 6 months post-procedure (2-3 mg i.c. nitrates). • Major adverse cardiac events (MACE) and Target Vessel Failure (TVF) at 30 days, 6 and 12 months • Circulating endothelial progenitor cell (EPC) count at the index procedure and 6 months post-procedure • CFR at index procedure and at follow-up • Protocol-related serious adverse events (SAEs) up to 12 months | — |
Countries
Netherlands
Outcome results
None listed