Elixir Medical Clinical Evaluation of the Novolimus-Eluting Coronary Stent System: A Randomized Study EXCELLA II STUDY

Study Overview
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Brief Summary
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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 IVUS endpoints as compared to the concurrently enrolled Medtronic Zotarolimus-Eluting Coronary Stent System in a randomized, single blind study of up to 200 male and female patients. In a Continued Access Registry of up to 100 patients receiving the DESyne Stent clinical-only endpoints will be evaluated. To evaluate the safety and effectiveness of the Elixir Novolimus-Eluting Coronary Stent System with bioabsorbable polymer as compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System control through clinical and angiographic endpoints.

Official Title
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A Randomized, Single Blind, Consecutive Enrollment Evaluation of the Elixir Novolimus-Eluting Coronary Stent System With Durable Polymer Compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the Treatment Of Patients With De Novo Native Coronary Artery Lesions And A Randomized, Consecutive Enrollment Evaluation of the Elixir Novolimus-Eluting Coronary Stent System With Bioabsorbable Polymer Compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the Treatment Of Patients With De Novo Native Coronary Artery Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Medtronic Endeavor Coronary Stent System
* Device: DESyne BD Novolimus Stent System
* Device: DESyne Novolimus Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. DESyne DES<br>Test arm: Intervention with DESyne Novolimus-Eluting Coronary Stent DESyne Novolimus Stent System | Device: DESyne Novolimus Stent System<br>* coronary stent implantation<br>|
| Active Comparator: 2. Medtronic Endeavor DES<br>Control arm: Intervention with Medtronic Endeavor Zotarolimus-Eluting Coronary Stent Medtronic Endeavor Coronary Stent System | Device: Medtronic Endeavor Coronary Stent System<br>* coronary stent implantation<br>|
| Experimental: 3. DESyne BD DES<br>Test arm: Intervention with DESyne BD Novolimus-Eluting Coronary Stent DESyne BD Novolimus Stent System | Device: DESyne BD Novolimus Stent System<br>* coronary stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent late lumen loss assessed by QCA |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-oriented Composite Endpoints |  | 1, 6, 9, and 12 months and annually to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease