Endothelial Function following stenting with Genous vs Drug-Eluting Stents - Vasomotion

OrbusNeich Medical BV0 sites36 target enrollmentNovember 8, 2007

Overview

No summary available.

Registry

who.int

Start Date

November 8, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

OrbusNeich Medical BV

•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 \<100% (minimum TIMI flow I at the time of the PCI
•procedure) (visual estimate);
•9\.The patient is willing to comply with the specified follow\-up evaluation;

•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 \< 100,000 cells/mm3 or \> 700,000 cells/mm3 or a WBC of \< 3,000 cells/mm3;
•6\.Documented or suspected liver disease (including laboratory evidence of hepatitis);
•7\.Recipient of heart transplant;
•8\.Any patient who previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti\-mouse Antibodies (HAMA);
•9\.Patient with a life expectancy less than the follow\-up period (6 months);
•10\.Known allergies to aspirin, clopidogrel bisulphate (Plavix?) and ticlopidine (Ticlid?), heparin, or stainless steel;