Elixir Medical Clinical Evaluation of the Novolimus-Eluting Coronary Stent System: A Randomized Study With a Single-Arm Registry "EXCELLA II STUDY" - Full Text View

Sponsored by:	Elixir Medical Corporation
Information provided by:	Elixir Medical Corporation
ClinicalTrials.gov Identifier:	NCT00792753

Purpose

Randomized Study To evaluate the safety and effectiveness of the Elixir Medical 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.

Single-Arm Registry To evaluate the safety and effectiveness of the Elixir Medical Novolimus-Eluting Coronary Stent System with Bioabsorbable Polymer through the assessment of clinical, angiographic and IVUS endpoints as compared to the Endeavor control in a single-arm registry enrolling up to 100 male and female patients.

Condition	Intervention	Phase
Coronary Artery Disease	Device: Medtronic Endeavor Coronary Stent System Device: Elixir Novolimus Stent System with bioabsorbable polymer Device: Elixir Novolimus Stent System with durable polymer	Phase II Phase III

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy 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 Non-Randomized, Consecutive Enrollment Evaluation of the Elixir Novolimus-Eluting Coronary Stent System With Bioabsorbable Polymer Compared to Contemporary Controls in the Treatment of Patients With De Novo Native Coronary Artery Lesions

Further study details as provided by Elixir Medical Corporation:

Primary Outcome Measures:

In-stent late lumen loss assessed by QCA [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Device-oriented Composite Endpoints [ Time Frame: 1, 6, 9, and 12 months and annually to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	October 2008
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1Novolimus-Eluting Coronary Stent with durable polymer: Experimental	Device: Elixir Novolimus Stent System with durable polymer coronary stent implantation
2. Medtronic Endeavor Zotarolimus-Eluting Coronary Stent: Active Comparator	Device: Medtronic Endeavor Coronary Stent System coronary stent implantation
3 Novolimus-Eluting Coronary Stent with bioabsorbable polymer: Experimental	Device: Elixir Novolimus Stent System with bioabsorbable polymer coronary stent implantation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792753

Contacts

Contact: Patrick W Serruys, MD, PhD

31 10 463 5036

p.w.j.c.serruys@erasmusmc.nl

Locations

Australia
Monash Medical Center	Not yet recruiting
Melbourne, Australia, 3168
Contact: Ian Meredith, MD 31-3-9594-4307 ian.meredith@med.monash.edu.au
Principal Investigator: Ian Meredith, MD
Belgium
University Hospital Gent	Not yet recruiting
Gent, Belgium, 9000
Contact: Yves Taeymans, MD 32 (0)9-240-2009 yves.taeymans@uzgent.be
Principal Investigator: Yves Taeymans, MD
Brazil
Instituto Dante Pazzanese	Not yet recruiting
Sao Paulo, Brazil, 0401210
Contact: Alexandre Abizaid, MD, PhD 55 (11) 5085-6325 aabizaid@uol.com.br
Principal Investigator: Alexandre Abizaid, MD, PhD
Germany
Universitäres Herz- und Gefäßzentrum	Recruiting
Hamburg, Germany, 22527
Contact: Joachim Schofer, MD 49 40 - 889 009 889 schofer@herz-hh.de
Principal Investigator: Joachim Schofer, MD
Netherlands
Thoraxcentrum	Not yet recruiting
Rotterdam, Netherlands, 3015
Contact: Patrick W. Serruys, MD, PhD 31 10 463 5036 p.w.j.c.serruys@erasmusmc.nl
Principal Investigator: Patrick W. Serruys, MD, PhD
New Zealand
Auckland City Hospital	Recruiting
Auckland, New Zealand, 1023
Contact: John Ormiston, MD 64 9 307 494 JohnO@adhb.govt.nz
Contact: Mark Webster, MD 64 9 307 494 mwebster@adhb.govt.nz
Principal Investigator: John Ormiston, MD
Principal Investigator: Mark Webster, MD
Poland
Jagiellonian University	Not yet recruiting
Krakow, Poland, 31-501
Contact: Dariusz Dudek, MD, PhD 48 12 424 71 81 mcdudek@cyf-kr.edu.pl
Principal Investigator: Dariusz Dudek, MD, PhD
Switzerland
University Hospital Bern	Not yet recruiting
Bern, Switzerland, 3010
Contact: Stephan Windecker, MD 41 (31) 6324497 Stephan.windecker@insel.ch
Principal Investigator: Stephan Windecker, MD

Sponsors and Collaborators

Elixir Medical Corporation

Investigators

Principal Investigator:

Patrick W Serruys, MD, PhD

Thoraxcentrum, Rotterdam, Netherlands

More Information

Responsible Party:	Elixir Medical Corporation ( Sara Toyloy, Executive Vice President, Regulatory, Clinical and Qualify Affairs )
Study ID Numbers:	ELX-CL-0801
Study First Received:	November 14, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00792753
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: National Committee of Ethics in Research; Belgium: Federal Agency for Medicinal Products and Health Products; Germany: German Institute of Medical Documentation and Information; New Zealand: Institutional Review Board; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Netherlands: Dutch Health Care Inspectorate

Keywords provided by Elixir Medical Corporation:

Coronary Artery Disease

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009