Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition (OPTIMA)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Heart Disease |
Device: Biolimus-eluting stent Device: Everolimus-eluting coronary stent |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition: A Randomized Comparison of the Biolimus A9-eluting and Everolimus-eluting Coronary Stents |
- Rate of stent strut malapposition [ Time Frame: 0 Days ] [ Designated as safety issue: No ]Apposition will be examined immediately following stent implantation following angiographic optimization of stent deployment
- Rate of stent strut tissue coverage [ Time Frame: At follow-up (one of either 3, 6, 12 or 15 months) ] [ Designated as safety issue: No ]Subjects will be randomized to follow-up at either one of the time points post stenting (3, 6, 12 or 15 months).
- Major Adverse Cardiac Events [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Biolimus-eluting stent |
Device: 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.
Other Name: Biomatrix Flex (Biosensors International)
|
| Active Comparator: Everolimus-eluting stent |
Device: Everolimus-eluting coronary stent
The everolimus-eluting coronary stent is a cobalt chromium platform stent with a permanent fluorinated copolymer matrix that eludes everolimus
Other Name: Promus (BSC)
|
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 still encountered in 20 to 40% of coronary lesions after implantation of bare metal stents, inferring frequent repeat revascularization procedures with a negative impact on quality of life and health care expenditures. Drug-eluting stents (DES), with their controlled release of therapeutic agents, have significantly reduced the rate of major adverse cardiac events (MACE) following coronary stent implantation, primarily by a reduction in restenosis and target lesion revascularization.
Optical coherence tomography (OCT) is an optical analogue of intravascular ultrasound (IVUS): it uses an infrared light source (wavelength 1310nm) and measures the backscatter of light in a technique similar to conventional ultrasound. With this technique a resolution up to 10μm in-vivo has been reported, a far better level of resolution compared with IVUS. Optical coherence tomography has been used in vivo and has detected early atherosclerotic plaques previously not visualised by IVUS. Segments with strut malapposition and the presence or thickness of neointimal hyperplasia can also be more accurately assessed with OCT compared with IVUS.
The present study will utilize the imaging capabilities of OCT to assess stent strut malapposition and tissue coverage in two different types of DES. The biolimus-eluting stent eludes biolimus from a biodegradable polylactic acid polymer on the abluminal surface of a stainless steel stent. This stent will be compared in a randomized fashion to the permanent polymer based everolimus-eluting coronary stent made of cobalt chromium alloy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
Contacts and Locations| Contact: Peter Barlis, MBBS PhD FRACP | +61 3 8405 8554 | peter.barlis@nh.org.au |
| Australia, Victoria | |
| The Northern Hospital | Recruiting |
| Epping, Victoria, Australia, 3076 | |
| Contact: Peter Barlis, MBBS MPH PhD FESC FCSANZ FRACP peter.barlis@nh.org.au | |
| Principal Investigator: Peter Barlis, MBBS MPH PhD FESC FCSANZ FRACP | |
| Principal Investigator: | Peter Barlis, MBBS PhD FRACP | Northern Hospital, Department of Cardiology, Victoria, Australia |
More Information
Publications:
| Responsible Party: | A/Prof. Peter Barlis MBBS, MPH, PhD, FESC, FCSANZ, FRACP, Northern Hospital, Victoria, Australia |
| ClinicalTrials.gov Identifier: | NCT01137019 History of Changes |
| Other Study ID Numbers: | OPTIMA A19/10 |
| Study First Received: | June 2, 2010 |
| Last Updated: | November 10, 2010 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Northern Hospital, Australia:
|
Drug-eluting stents Tomography, Optical Coherence |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Everolimus Sirolimus |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013