Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition

NCT01137019 | Unknown Phase 3 DMC

• 1 other identifier: OPTIMA A19/10
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

Drug-eluting stents; Tomography, Optical Coherence

Outcome Measures

Primary Outcomes (2)

• Rate of stent strut malapposition

  Apposition will be examined immediately following stent implantation following angiographic optimization of stent deployment

  0 Days

• Rate of stent strut tissue coverage

  Subjects will be randomized to follow-up at either one of the time points post stenting (3, 6, 12 or 15 months).

  At follow-up (one of either 3, 6, 12 or 15 months)

Secondary Outcomes (1)

• Major Adverse Cardiac Events

  15 months

Study Arms (2)

Biolimus-eluting stent

ACTIVE COMPARATOR

Device: Biolimus-eluting stent

Everolimus-eluting stent

ACTIVE COMPARATOR

Device: Everolimus-eluting coronary stent

Interventions

Biolimus-eluting stent DEVICE

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.

Also known as: Biomatrix Flex (Biosensors International)

Biolimus-eluting stent

Everolimus-eluting coronary stent DEVICE

The everolimus-eluting coronary stent is a cobalt chromium platform stent with a permanent fluorinated copolymer matrix that eludes everolimus

Also known as: Promus (BSC)

Everolimus-eluting stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Peter Barlis: lead
• Biosensors International: collaborator

Study Sites (1)

The Northern Hospital

Epping, Victoria, 3076, Australia

Location

Related Publications (4)

• 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.

  PMID: 19889649 BACKGROUND

• 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.

  PMID: 19298163 BACKGROUND

• 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.

  PMID: 19155076 BACKGROUND

• 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.

  PMID: 18775576 BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Peter Barlis, MBBS PhD FRACP

  Northern Hospital, Department of Cardiology, Victoria, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine, Principal Investigator

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 4, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

AU (1)