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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: DESyne BD Novolimus Stent System; Device: DESyne Novolimus Stent System; Device: Medtronic Endeavor Coronary Stent System

• Registration Number: NCT00792753
• Lead Sponsor: Elixir Medical Corporation

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-18
• Primary Completion: 2011-11
• Study Completion: 2014-03-08
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3. DESyne BD DES	DESyne BD Novolimus Stent System	Test arm: Intervention with DESyne BD Novolimus-Eluting Coronary Stent DESyne BD Novolimus Stent System
1. DESyne DES	DESyne Novolimus Stent System	Test arm: Intervention with DESyne Novolimus-Eluting Coronary Stent DESyne Novolimus Stent System
2. Medtronic Endeavor DES	Medtronic Endeavor Coronary Stent System	Control arm: Intervention with Medtronic Endeavor Zotarolimus-Eluting Coronary Stent Medtronic Endeavor Coronary Stent System

Primary Outcome Measures

Name	Time	Method
In-stent late lumen loss assessed by QCA	9 months

Secondary Outcome Measures

Name	Time	Method
Device-oriented Composite Endpoints	1, 6, 9, and 12 months and annually to 5 years

Trial Locations

Locations (8)

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Universitäres Herz- und Gefäßzentrum; 🇩🇪 Hamburg, Germany

Monash Medical Center; 🇦🇺 Melbourne, Australia

University Hospital Bern; 🇨🇭 Bern, Switzerland

Thoraxcentrum; 🇳🇱 Rotterdam, Netherlands

University Hospital Gent; 🇧🇪 Gent, Belgium

Jagiellonian University; 🇵🇱 Krakow, Poland

Instituto Dante Pazzanese; 🇧🇷 Sao Paulo, Brazil