Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition (OPTIMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01137019
Recruitment Status : Unknown
Verified August 2014 by Dr Peter Barlis, Northern Hospital, Australia.
Recruitment status was:  Active, not recruiting
First Posted : June 4, 2010
Last Update Posted : August 5, 2014
Biosensors International
Information provided by (Responsible Party):
Dr Peter Barlis, Northern Hospital, Australia

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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: Biolimus-eluting stent Device: Everolimus-eluting coronary stent Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Rate of stent strut malapposition [ Time Frame: 0 Days ]
    Apposition will be examined immediately following stent implantation following angiographic optimization of stent deployment

  2. Rate of stent strut tissue coverage [ Time Frame: At follow-up (one of either 3, 6, 12 or 15 months) ]
    Subjects will be randomized to follow-up at either one of the time points post stenting (3, 6, 12 or 15 months).

Secondary Outcome Measures :
  1. Major Adverse Cardiac Events [ Time Frame: 15 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01137019

Australia, Victoria
The Northern Hospital
Epping, Victoria, Australia, 3076
Sponsors and Collaborators
Dr Peter Barlis
Biosensors International
Principal Investigator: Peter Barlis, MBBS PhD FRACP Northern Hospital, Department of Cardiology, Victoria, Australia

Responsible Party: Dr Peter Barlis, Associate Professor of Medicine, Principal Investigator, Northern Hospital, Australia Identifier: NCT01137019     History of Changes
Other Study ID Numbers: OPTIMA A19/10
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014

Keywords provided by Dr Peter Barlis, Northern Hospital, Australia:
Drug-eluting stents
Tomography, Optical Coherence

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Inflammatory Agents