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

Elixir Medical

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Medtronic Endeavor Coronary Stent System; Device: DESyne BD Novolimus Stent System; Device: DESyne Novolimus Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00792753

ELX-CL-0801

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 3 patient groups

1. DESyne DES

Experimental group

Description:

Test arm: Intervention with DESyne Novolimus-Eluting Coronary Stent DESyne Novolimus Stent System

Treatment:

Device: DESyne Novolimus Stent System

2. Medtronic Endeavor DES

Active Comparator group

Description:

Control arm: Intervention with Medtronic Endeavor Zotarolimus-Eluting Coronary Stent Medtronic Endeavor Coronary Stent System

Treatment:

Device: Medtronic Endeavor Coronary Stent System

3. DESyne BD DES

Experimental group

Description:

Test arm: Intervention with DESyne BD Novolimus-Eluting Coronary Stent DESyne BD Novolimus Stent System

Treatment:

Device: DESyne BD Novolimus Stent System