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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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
Other publications