Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™ (OISTER)

Clearstream Technologies

Status and phase

Unknown

Phase 4

Conditions

Coronary Artery Disease

Acute Coronary Syndrome

Treatments

Device: Intrepide Trapidil eluting stent

Device: Taxus drug eluting stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00914420

CST10

Details and patient eligibility

About

Patients presenting with ACS (Acute Coronary Syndrome) in the emergency department will be screened for clinical eligibility and asked to sign informed consent to the study.

A total of 40 patients will be randomized. 20 of them will receive a Trapidil eluting stent (Intrepide™ stent), 20 will receive a Paclitaxel eluting stent (Taxus™ stent). After 90 days the patients who were treated with the INTREPIDE stent in the first lesion will be treated with the Taxus stent in the second lesion. After 90 days the patients who were treated with the Taxus stent in the first lesion will be treated with the INTREPIDE stent in the second lesion.

Coronary angiography will be performed through the femoral (groin) or radial (wrist) artery with the use of standard techniques. The doctor will determine if the patient is qualified for enrolment at the end of the diagnostic coronary angiogram

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical

>18 years of age,
symptoms of non ST-elevation ACS (defined by the ACC/AHA criteria) for 30 min but <48 h
Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board

Angiographic

reference vessel diameter of culprit/target lesion between 2.25 to 3.5 mm (visual estimate)
discrete target lesion (maximum length of 28 mm by visual estimation)
target lesion is in a native coronary artery
presence of another lesion more than 70% in a vessel different from the culprit one amenable of planned percutaneous treatment 90 days thereafter.

Exclusion criteria

Clinical

previously documented left ventricular ejection fraction of less than 30%
estimated life expectancy of less than 12 months
a history of bleeding diathesis, leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction
participation in another study
inability to give informed consent owing to prolonged cardiopulmonary resuscitation
and dominant Renal impairment (serum creatinine > 2.0 mg/dl) Angiographic
non-culprit lesion located in the proximal LAD or in a proximal and dominant Circumflex artery
previous PCI of the target vessels restenosis or stent thrombosis as culprit lesion
unprotected left main coronary artery disease
non-culprit lesion located in a vein graft
severe multivessel disease (three major epicardial vessel disease) need of overlapping stenting for one lesion