Status:
COMPLETED
Elixir Medical Clinical Evaluation of the Novolimus-Eluting Coronary Stent System: A Randomized Study "EXCELLA II STUDY"
Lead Sponsor:
Elixir Medical Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized Study To evaluate the safety and effectiveness of the Elixir Medical DESyne Novolimus-Eluting Coronary Stent System with Durable Polymer through the assessment of clinical, angiographic and...
Eligibility Criteria
Inclusion
- The patient has a planned intervention of a single lesion in one or two separate major epicardial territories. Each lesion/vessel must meet the following criteria:
- De novo
- The target lesion reference site must be visually estimated to be \> 2.5 mm and \< 3.5 mm in diameter.
- The target vessel must be a major coronary artery or major branch with a visually estimated stenosis of \> 50% and \<100%.
- The visually estimated target lesion must be able to be covered by a single, 14, 18 or 28mm stent Elixir Stent or a single 14, 18, 24 or 30mm Endeavor Stent. Note that the 8mm Endeavor Stent will not be used in this study.
- Maximum lesion length is 24 mm.
- \> TIMI 1 coronary flow.
Exclusion
- The patient has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, mTOR inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, or sensitivity to contrast which cannot be adequately premedicated.
- There will be an untreated significant lesion of \> 40% diameter stenosis remaining proximal or distal to the target site after the planned intervention.
- Total occlusion or TIMI 0 coronary flow in the target vessel.
- Restenosis lesion
- The proximal target vessel or target lesion is severely calcified by visual assessment.
- Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX.
- Lesion involvement of a significant side branch (branch diameter \> 2 mm) that would be covered by stenting.
- The patient has suffered a myocardial infarction with total creatine kinase (CK) \>2 times normal within the past 72 hours (exactly three days).
- The patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- The patient suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleed within the past six months.
- The patient has renal insufficiency as determined by a creatinine of \> 2.0mg/dl.
- The target lesion, or the target vessel proximal to the target lesion, contains thrombus.
- Documented left ventricular ejection fraction of \< 25%.
- The patient is a recipient of a heart transplant.
- The patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion or extreme anti-coagulation.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2014
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00792753
Start Date
October 1 2008
End Date
March 8 2014
Last Update
April 8 2020
Active Locations (8)
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1
Monash Medical Center
Melbourne, Australia, 3168
2
University Hospital Gent
Ghent, Belgium, 9000
3
Instituto Dante Pazzanese
São Paulo, Brazil, 0401210
4
Universitäres Herz- und Gefäßzentrum
Hamburg, Germany, 22527