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

Resource links provided by NLM:


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
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014