Status:
COMPLETED
Optical Coherence Tomography for EVERolimus Eluting STent
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Collaborating Sponsors:
Case Western Reserve University
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Compared with bare metal stents (BMS), both paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) significantly reduce angiographic restenosis and the need for repeat revascularization in...
Detailed Description
This is a prospective single center clinical study designed to evaluate the long term struts coverage and vessel wall response (abnormal intraluminal defects, strut malapposition, vessel espansions) t...
Eligibility Criteria
Inclusion
- Patient is ≥ 18 years of age
- Patient is eligible for percutaneous coronary intervention (PCI)
- Patient has documented stable angina pectoris (Canadian Cardiovascular Society \[CCS\] Classification 1, 2, 3, or 4) or documented silent ischemia; or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C)
- Patient demonstrates a left ventricular ejection fraction (LVEF) of ≥ 40% as measured prior to enrollment
- Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect.
- Angiographic Inclusion Criteria
- Target lesion must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.50 mm and ≤ 3,75 mm.
- Target lesion length must measure (by visual estimate) ≤ 24 mm.
- Target lesion must be in a major coronary artery or branch with visually estimated stenosis ≥ 50% and \<100% with TIMI flow \>1.
Exclusion
- General Exclusion Criteria
- The patient has a life expectancy of less than 24 months due to another medical condition
- Patient has a history of hypersensitivity to everolimus or paclitaxel or structurally related compounds
- Patient exhibits cardiogenic shock (systolic pressure \< 80mm Hg and PCWP \> 20mm Hg or cardiac index \<1.8 liters/minute/m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure\>80 mm Hg) for any time within 24 hours prior to index procedure
- Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine \> 2.0 mg/dl or 177 μmol/l)
- Planned cardiac surgery procedure ≤ 6 months post-index procedure
- Patient demonstrates evidence of a acute myocardial infarction (eg. STEMI or enzyme elevation CK \> 2X local laboratory's ULN unless CK-MB is \< 2X ULN) 7)
- Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months
- Patient demonstrates evidence of leukopenia (leukocyte count \< 3.5 X 109/liter)
- Patient demonstrates evidence of thrombocytopenia (platelet count \< 100,000/mm3) or thrombocytosis (\>750,000/mm3)
- Patient is contraindicated to Aspirin (successful prior desensitization to Aspirin is not an exclusion), clopidogrel, or ticlopidine
- Patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
- Patient has been treated with paclitaxel, everolimus or other chemotherapeutic agents within 12-months prior to planned index procedure
- Anticipated treatment with paclitaxel, everolimus or oral rapamycin during any period in the 6-months after the index procedure
- Known allergy to stainless steel
- Female or male with known intention to procreate within 3 months after the index procedure (due to the exposure to paclitaxel and unknown affect it may have on the fetus)
- Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 9 months post index procedure
- Patient that in the opinion of the investigator is not clinically appropriate for OCT evaluation.
- Angiographic Exclusion Criteria
- Evidence of thrombus of the study vessel, based on angiography or IVUS
- Study lesion is totally occluded (TIMI flow ≤ 1) either at baseline or before predilatation
- Study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified, by visual estimate
- Study lesion is ostial in location (within 5.0 mm of vessel origin)
- Study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a \>60 degree bend in the vessel
- Study lesion involves a bifurcation with a diseased (\>50% stenotic) branch - Left main coronary artery disease (stenosis \>50%) whether protected or unprotected
- Target lesion length \> 24 mm, based on visual estimate by operator
- Target vessel diameter \> 3.75 mm, based on visual estimate by operator
- Target vessel diameter \< 2.5 mm based on visual estimate by operator
- Pre-treatment of the target lesion (excluding predilation) with another interventional device.
- Target lesion is restenotic from previous intervention
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01146080
Start Date
February 1 2010
End Date
October 1 2015
Last Update
October 16 2015
Active Locations (1)
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1
Cardiovascular Department Ospedali Riuniti di Bergamo
Bergamo, BG, Italy, 24128