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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792753
• Other study ID #: ELX-CL-0801
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: March 8, 2014

Study information

• Verified date: April 2020
• Source: Elixir Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: March 8, 2014
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Medtronic Endeavor Coronary Stent System
coronary stent implantation
• DESyne BD Novolimus Stent System
coronary stent implantation
• DESyne Novolimus Stent System
coronary stent implantation

Locations

Country	Name	City	State
Australia	Monash Medical Center	Melbourne
Belgium	University Hospital Gent	Gent
Brazil	Instituto Dante Pazzanese	Sao Paulo
Germany	Universitäres Herz- und Gefäßzentrum	Hamburg
Netherlands	Thoraxcentrum	Rotterdam
New Zealand	Auckland City Hospital	Auckland
Poland	Jagiellonian University	Krakow
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Elixir Medical Corporation

Countries where clinical trial is conducted

Australia,  Belgium,  Brazil,  Germany,  Netherlands,  New Zealand,  Poland,  Switzerland, 

References & Publications (1)

Iqbal J, Verheye S, Abizaid A, Ormiston J, de Vries T, Morrison L, Toyloy S, Fitzgerald P, Windecker S, Serruys PW. DESyne novolimus-eluting coronary stent is superior to Endeavor zotarolimus-eluting coronary stent at five-year follow-up: final results of — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late lumen loss assessed by QCA		9 months
Secondary	Device-oriented Composite Endpoints		1, 6, 9, and 12 months and annually to 5 years