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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medtronic Endeavor Coronary Stent System
DESyne BD Novolimus Stent System
DESyne Novolimus Stent System
Sponsored by
Elixir Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Monash Medical Center
  • University Hospital Gent
  • Instituto Dante Pazzanese
  • Universitäres Herz- und Gefäßzentrum
  • Thoraxcentrum
  • Auckland City Hospital
  • Jagiellonian University
  • University Hospital Bern

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

1. DESyne DES

2. Medtronic Endeavor DES

3. DESyne BD DES

Arm Description

Test arm: Intervention with DESyne Novolimus-Eluting Coronary Stent DESyne Novolimus Stent System

Control arm: Intervention with Medtronic Endeavor Zotarolimus-Eluting Coronary Stent Medtronic Endeavor Coronary Stent System

Test arm: Intervention with DESyne BD Novolimus-Eluting Coronary Stent DESyne BD Novolimus Stent System

Outcomes

Primary Outcome Measures

In-stent late lumen loss assessed by QCA

Secondary Outcome Measures

Device-oriented Composite Endpoints

Full Information

First Posted
November 14, 2008
Last Updated
April 6, 2020
Sponsor
Elixir Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00792753
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
March 8, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elixir Medical Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. DESyne DES
Arm Type
Experimental
Arm Description
Test arm: Intervention with DESyne Novolimus-Eluting Coronary Stent DESyne Novolimus Stent System
Arm Title
2. Medtronic Endeavor DES
Arm Type
Active Comparator
Arm Description
Control arm: Intervention with Medtronic Endeavor Zotarolimus-Eluting Coronary Stent Medtronic Endeavor Coronary Stent System
Arm Title
3. DESyne BD DES
Arm Type
Experimental
Arm Description
Test arm: Intervention with DESyne BD Novolimus-Eluting Coronary Stent DESyne BD Novolimus Stent System
Intervention Type
Device
Intervention Name(s)
Medtronic Endeavor Coronary Stent System
Intervention Description
coronary stent implantation
Intervention Type
Device
Intervention Name(s)
DESyne BD Novolimus Stent System
Intervention Description
coronary stent implantation
Intervention Type
Device
Intervention Name(s)
DESyne Novolimus Stent System
Intervention Description
coronary stent implantation
Primary Outcome Measure Information:
Title
In-stent late lumen loss assessed by QCA
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Device-oriented Composite Endpoints
Time Frame
1, 6, 9, and 12 months and annually to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick W Serruys, MD, PhD
Organizational Affiliation
Thoraxcentrum, Rotterdam, Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monash Medical Center
City
Melbourne
ZIP/Postal Code
3168
Country
Australia
Facility Name
University Hospital Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Instituto Dante Pazzanese
City
Sao Paulo
ZIP/Postal Code
0401210
Country
Brazil
Facility Name
Universitäres Herz- und Gefäßzentrum
City
Hamburg
ZIP/Postal Code
22527
Country
Germany
Facility Name
Thoraxcentrum
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Jagiellonian University
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26465374
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.
Results Reference
result

Learn more about this trial

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

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