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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/NCT01137019




Registration number
NCT01137019
Ethics application status
Date submitted
2/06/2010
Date registered
4/06/2010
Date last updated
5/08/2014

Titles & IDs
Public title
Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition
Scientific title
Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition: A Randomized Comparison of the Biolimus A9-eluting and Everolimus-eluting Coronary Stents
Secondary ID [1] 0 0
OPTIMA A19/10
Universal Trial Number (UTN)
Trial acronym
OPTIMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart 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 - Biolimus-eluting stent
Treatment: Devices - Everolimus-eluting coronary stent

Active Comparator: Biolimus-eluting stent -

Active Comparator: Everolimus-eluting stent -


Treatment: Devices: Biolimus-eluting stent
The biolimus-eluting coronary stent contains a stainless steel platform on which an abluminally coated polylactic acid (PLA) biodegradable polymer is placed that eludes biolimus-A9.

Treatment: Devices: Everolimus-eluting coronary stent
The everolimus-eluting coronary stent is a cobalt chromium platform stent with a permanent fluorinated copolymer matrix that eludes everolimus
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of stent strut malapposition
Timepoint [1] 0 0
0 Days
Primary outcome [2] 0 0
Rate of stent strut tissue coverage
Timepoint [2] 0 0
At follow-up (one of either 3, 6, 12 or 15 months)
Secondary outcome [1] 0 0
Major Adverse Cardiac Events
Timepoint [1] 0 0
15 months

Eligibility
Key inclusion criteria
- Age = 18 years

- Symptomatic coronary artery disease including patients with chronic stable angina,
silent ischemia, and acute coronary syndromes including non-ST elevation myocardial
infarction

- Presence of one or more coronary artery stenosis > 50% in a native coronary artery
with a reference diameter ranging from 2.25 to 4.0 mm which can be covered with one or
multiple stents

- No limitation to the number of treated lesions, number of vessels or lesion length
according to the randomization group
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium,
Biolimus, everolimus, contrast material

- Acute ST-segment elevation myocardial infarction

- Bypass graft

- Inability to provide informed consent

- Pregnancy

- Planned surgery within 12 months of PCI unless dual antiplatelet therapy is maintained
throughout the peri-surgical period

- Left ventricular ejection fraction < 25%

- Serum creatinine > 180mmol/L

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

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2014
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 0 0
3076 - Epping

Funding & Sponsors
Primary sponsor type
Other
Name
Dr Peter Barlis
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Biosensors International
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to use a high-resolution intracoronary imaging modality, called
optical coherence tomography (OCT) to examine two different types of coronary artery stents
used to treat patients with coronary artery disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01137019
Trial related presentations / publications
Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, Ferrante G, Wandel S, Windecker S, van Es GA, Eerdmans P, Juni P, di Mario C. An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J. 2010 Jan;31(2):165-76. doi: 10.1093/eurheartj/ehp480. Epub 2009 Nov 4.
Barlis P, van Soest G, Serruys PW, Regar E. Intracoronary optical coherence tomography and the evaluation of stents. Expert Rev Med Devices. 2009 Mar;6(2):157-67. doi: 10.1586/17434440.6.2.157.
Barlis P, Dimopoulos K, Tanigawa J, Dzielicka E, Ferrante G, Del Furia F, Di Mario C. Quantitative analysis of intracoronary optical coherence tomography measurements of stent strut apposition and tissue coverage. Int J Cardiol. 2010 May 28;141(2):151-6. doi: 10.1016/j.ijcard.2008.11.204. Epub 2009 Jan 19.
Tanigawa J, Barlis P, Dimopoulos K, Dalby M, Moore P, Di Mario C. The influence of strut thickness and cell design on immediate apposition of drug-eluting stents assessed by optical coherence tomography. Int J Cardiol. 2009 May 15;134(2):180-8. doi: 10.1016/j.ijcard.2008.05.069. Epub 2008 Sep 4.
Public notes

Contacts
Principal investigator
Name 0 0
Peter Barlis, MBBS PhD FRACP
Address 0 0
Northern Hospital, Department of Cardiology, Victoria, Australia
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/NCT01137019