Optical Coherence Tomography in Long Lesions (LONG OCT)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Percutaneous Coronary Intervention, Drug Eluting Stent, Optical Coherence Tomography, Thrombosi, Long lesions in native vessels requiring overlap
Eligibility Criteria
Inclusion Criteria:
- Patient must be at least 18 years of age
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
- Native coronary artery disease with >75% diameter stenosis (no prior stent implant, no prior brachytherapy)
- Lesion length > 20 mm
- Vessel size between 2.5 and 3.5 mm
- Multiple, overlapped Endeavor Resolute stents placement (intention to overlap > 4 mm).
Exclusion Criteria:
- Left main coronary artery disease
- Lesions in coronary artery bypass grafts
- Acute myocardial infarction
- Killip class IV
- Recent major bleeding (6 months)
- Renal failure with creatinine value > 2.5 mg/dl
- Left ventricular global ejection fraction ≤ 30%.
- Allergy to aspirin and or clopidogrel/ticlopidine
- Patient in anticoagulant therapy
- No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels [> 3.5 mm in diameter])
- Target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy) < 9 months prior to index procedure
- Target lesion restenotic from previous stent implantation
- Any lesion (target or non-target) that has been previously treated with brachytherapy
Sites / Locations
- Cardiovascular Department Ospedali Riuniti di Bergamo
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
ODESSA
Resolute Sprint arm
ODESSA trial (NCT 00693030)Patients were randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. At 6-months follow-up coronary angiography (QCA), IVUS and Optical Coherence Tomography assessments were made. Data reported in J. Am. Coll. Cardiol. Intv. 2010;3;531-539. DOI 10.1016/j.jcin.2010.02.008.
Zotarolimus Eluting stents (Resolute Sprint) implanted in overlap to treat long coronary lesions