A Study of the Presillion Stent in de Novo Coronary Lesions (PRESILLION)

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease Read More

Inclusion Criteria:

• The patient must be >= 18 years of age.
• Patient is eligible for percutaneous coronary intervention (PCI).
• Acceptable candidate for coronary artery bypass surgery (CABG).
• Female patients of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment and utilize reliable birth control for trial duration.
• Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) or unstable angina pectoris (Braunwald Classification B&C, I-II-III) or patients with documented silent ischemia.
• Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries.
• Target reference vessel diameter of both lesions must be >= 2.5mm and <= 4.0mm in diameter (visual estimate).
• Target lesion length must be <= 30mm and be covered by one study stent.
• Target lesion stenosis for both lesions is > 50% and < 100% (visual estimate).
• At least TIMI I coronary flow.
• Patient is willing to comply with the specified follow-up evaluation.
• Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee.

Exclusion Criteria:

• Recent myocardial infarction (either STEMI or non STEMI < 48 hours prior to planned index procedure).
• The patient has unstable angina classified as Braunwald A I-II-III.
• The patient has unprotected left main coronary artery disease (stenosis >50%).
• A significant (> 50%) stenosis proximal or distal to the target lesion.
• Angiographic evidence of thrombus within the target lesion.
• Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated and/or an excessively tortuous vessel which makes it unsuitable for stent delivery and deployment.
• Left ventricular ejection fraction <= 25%.
• Totally occluded lesion (TIMI 0 level).
• The patient has impaired renal function (creatinine 3.0mg/dL) at the time of treatment.
• The patient had a Cerebrovascular Accident (CVA) within the past 6 months.
• Prior stent within 10mm of target lesion.
• The target lesion is ostial in location (within 3.0mm of vessel origin).
• The target lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >= 2.0mm in diameter (or side branch requiring intervention of protection).
• The target lesion is located in a bypass graft. Note: stenting of lesions in bypassed native coronary arteries is allowed.
• Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix ®) and ticlopidine (Ticlid ®), heparin, cobalt chromium, contrast agent (that cannot be managed medically).
• The patient has any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
• The patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
• Intervention of another lesion within 30 days prior to, or is planned or highly probably to be performed 30 days after the index procedure.