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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00792753




Registration number
NCT00792753
Ethics application status
Date submitted
14/11/2008
Date registered
18/11/2008
Date last updated
8/04/2020

Titles & IDs
Public title
Elixir Medical Clinical Evaluation of the Novolimus-Eluting Coronary Stent System: A Randomized Study "EXCELLA II STUDY"
Scientific 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
Secondary ID [1] 0 0
ELX-CL-0801
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Medtronic Endeavor Coronary Stent System
Treatment: Devices - DESyne BD Novolimus Stent System
Treatment: Devices - DESyne Novolimus Stent System

Experimental: 1. DESyne DES - Test arm: Intervention with DESyne Novolimus-Eluting Coronary Stent DESyne Novolimus Stent System

Active Comparator: 2. Medtronic Endeavor DES - Control arm: Intervention with Medtronic Endeavor Zotarolimus-Eluting Coronary Stent Medtronic Endeavor Coronary Stent System

Experimental: 3. DESyne BD DES - Test arm: Intervention with DESyne BD Novolimus-Eluting Coronary Stent DESyne BD Novolimus Stent System


Treatment: Devices: Medtronic Endeavor Coronary Stent System
coronary stent implantation

Treatment: Devices: DESyne BD Novolimus Stent System
coronary stent implantation

Treatment: Devices: DESyne Novolimus Stent System
coronary stent implantation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
In-stent late lumen loss assessed by QCA
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
Device-oriented Composite Endpoints
Timepoint [1] 0 0
1, 6, 9, and 12 months and annually to 5 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/03/2014
Sample size
Target
Accrual to date
Final
360
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Center - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Gent
Country [2] 0 0
Brazil
State/province [2] 0 0
Sao Paulo
Country [3] 0 0
Germany
State/province [3] 0 0
Hamburg
Country [4] 0 0
Netherlands
State/province [4] 0 0
Rotterdam
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
Poland
State/province [6] 0 0
Krakow
Country [7] 0 0
Switzerland
State/province [7] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Elixir Medical Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00792753
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick W Serruys, MD, PhD
Address 0 0
Thoraxcentrum, Rotterdam, Netherlands
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00792753