Status:
UNKNOWN
Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition
Lead Sponsor:
Dr Peter Barlis
Collaborating Sponsors:
Biosensors International
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 p...
Detailed Description
The development of coronary stents has significantly improved the safety and efficacy of percutaneous coronary intervention (PCI) compared to balloon angioplasty alone. Nevertheless, restenosis is sti...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01137019
Start Date
October 1 2010
End Date
December 1 2014
Last Update
August 5 2014
Active Locations (1)
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1
The Northern Hospital
Epping, Victoria, Australia, 3076