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Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms (APPOSE)

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.
 
ClinicalTrials.gov Identifier: NCT01776567
Recruitment Status : Unknown
Verified August 2014 by A/Prof. Peter Barlis, Northern Hospital, Australia.
Recruitment status was:  Recruiting
First Posted : January 28, 2013
Last Update Posted : August 5, 2014
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
A/Prof. Peter Barlis, Northern Hospital, Australia

Brief Summary:

The purpose of the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months) using optical coherence tomography.

Hypotheses:

  1. The alloy composition and strut design of a drug-eluting stent has a direct bearing on stent apposition measured using OCT.
  2. Stent design and alloy composition have a direct influence on radial support and scaffold shrinkage.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Everolimus eluting stents Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms.
Study Start Date : July 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cobalt Chromium Everolimus-eluting stent (Xience Prime)
Cobalt Chromium Everolimus-eluting stent (Xience Prime)
Device: Everolimus eluting stents
Active Comparator: Platinum Chromium Everolimus-eluting stent (Promus Element)
Platinum Chromium Everolimus-eluting stent (Promus Element)
Device: Everolimus eluting stents



Primary Outcome Measures :
  1. • Percent incomplete stent apposition using OCT of the CoCr-EES versus the PtCr-EES stent inflated to nominal pressure and following optimal post-dilatation. Stent length (mm) at implantation following nominal pressure and following post-dilatation [ Time Frame: Immediately following stent deployment ]

Secondary Outcome Measures :
  1. Percentage of uncovered stent struts [ Time Frame: 6 mths post initial PCI procedure ]
  2. Mean neointimal tissue thickness (microns) [ Time Frame: 6 months post initial PCI Procedure ]
  3. Stent length (mm) measured using OCT [ Time Frame: 6 months post initial PCI procedure ]


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
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction
  3. Presence of one or more coronary artery stenosis > 50% in a native coronary artery with a reference diameter ranging from 2.25 to 4.25 mm which can be covered with one or multiple stents
  4. No limitation to the number of treated lesions or number of vessels according to the randomization group
  5. De-novo native coronary disease with complex lesions involving: Bifurcations, chronic occlusions > 3 months, lesions > 20mm in length or moderately/heavily calcified lesions of any length

Exclusion Criteria:

  1. Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, platinum chromium, everolimus, contrast material
  2. Acute ST-segment elevation myocardial infarction
  3. Type A lesion including vessel angulation <45 degrees
  4. Bypass graft
  5. Inability to provide informed consent
  6. Pregnancy
  7. Planned surgery within 12 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
  8. Left ventricular ejection fraction < 25%
  9. 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 ClinicalTrials.gov identifier (NCT number): NCT01776567


Contacts
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Contact: Peter Barlis, MBBS MPH PHD FESC FRACP +61 3 8405 8554 pbarlis@unimelb.edu.au

Locations
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Australia, New South Wales
Concord Repatriation Hospital Not yet recruiting
Concord, New South Wales, Australia
Contact: Harry Lowe         
Sub-Investigator: Harry Lowe         
Australia, Queensland
The Prince Charles Hospital Not yet recruiting
Brisbane, Queensland, Australia
Contact: Darren Walters         
Sub-Investigator: Darren Walters         
Australia, Victoria
Northern Hospital Recruiting
Epping, Victoria, Australia, 3076
Contact: Rita Wong       rita.wong@nh.org.au   
Principal Investigator: Peter Barlis, MBBS PHD FRACP         
St Vincent's Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3065
Contact: Robert Whitbourn         
Sub-Investigator: Robert Whitbourn         
Sponsors and Collaborators
Northern Hospital, Australia
Abbott Medical Devices
Investigators
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Principal Investigator: Peter Barlis Northern Hospital

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Responsible Party: A/Prof. Peter Barlis, Interventional Cardiologist, Northern Hospital, Australia
ClinicalTrials.gov Identifier: NCT01776567    
Other Study ID Numbers: 01/12
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014
Keywords provided by A/Prof. Peter Barlis, Northern Hospital, Australia:
coronary artery disease
stents
optical imaging
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chromium
Cobalt
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances