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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Northern Hospital, Australia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Biosensors International
Information provided by:
Northern Hospital, Australia
ClinicalTrials.gov Identifier:
NCT01137019
First received: June 2, 2010
Last updated: November 10, 2010
Last verified: May 2010
  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

Resource links provided by NLM:


Further study details as provided by Northern Hospital, Australia:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137019

Contacts
Contact: Peter Barlis, MBBS PhD FRACP +61 3 8405 8554 peter.barlis@nh.org.au

Locations
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         
Sponsors and Collaborators
Northern Hospital, Australia
Biosensors International
Investigators
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 July 23, 2014