Clinical trial NCT00792753: Elixir Medical Clinical Evaluation of the Novolimus-Eluting Coronary Stent System: A Randomized Study "EXCELLA II STUDY"
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Lead sponsor: Elixir Medical Corporation
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: In-stent late lumen loss assessed by QCA
timeFrame: 9 months
Secondary outcomes:
measure: Device-oriented Composite Endpoints
timeFrame: 1, 6, 9, and 12 months and annually to 5 years
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Monash Medical Center
city: Gent
country: Belgium
facility: University Hospital Gent
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum
city: Rotterdam
country: Netherlands
facility: Thoraxcentrum
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Krakow
country: Poland
facility: Jagiellonian University
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: Thoraxcentrum, Rotterdam, Netherlands
name: Patrick W Serruys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 the multicentre EXCELLA II randomised controlled trial. EuroIntervention. 2016 Dec 10;12(11):e1336-e1342. doi: 10.4244/EIJY15M10_04.