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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elixir Medical Corporation
ClinicalTrials.gov Identifier:
NCT00792753
First received: November 14, 2008
Last updated: December 4, 2013
Last verified: December 2013
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1Novolimus-Eluting Coronary Stent with durable polymer Device: Elixir Novolimus Stent System with durable polymer
coronary stent implantation
Active Comparator: 2. Medtronic Endeavor Zotarolimus-Eluting Coronary Stent Device: Medtronic Endeavor Coronary Stent System
coronary stent implantation
Experimental: 3 Novolimus-Eluting Coronary Stent with bioabsorbable polymer 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia
Monash Medical Center
Melbourne, Australia, 3168
Belgium
University Hospital Gent
Gent, Belgium, 9000
Brazil
Instituto Dante Pazzanese
Sao Paulo, Brazil, 0401210
Germany
Universitäres Herz- und Gefäßzentrum
Hamburg, Germany, 22527
Netherlands
Thoraxcentrum
Rotterdam, Netherlands, 3015
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
Poland
Jagiellonian University
Krakow, Poland, 31-501
Switzerland
University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
Elixir Medical Corporation
Investigators
Principal Investigator: Patrick W Serruys, MD, PhD Thoraxcentrum, Rotterdam, Netherlands
  More Information

No publications provided

Responsible Party: Elixir Medical Corporation
ClinicalTrials.gov Identifier: NCT00792753     History of Changes
Other Study ID Numbers: ELX-CL-0801
Study First Received: November 14, 2008
Last Updated: December 4, 2013
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

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014