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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Northern Hospital, Australia
Sponsor:
Collaborator:
Abbott Vascular
Information provided by (Responsible Party):
A/Prof. Peter Barlis, Northern Hospital, Australia
ClinicalTrials.gov Identifier:
NCT01776567
First received: August 11, 2012
Last updated: August 2, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: Everolimus eluting stents
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms.

Resource links provided by NLM:


Further study details as provided by Northern Hospital, Australia:

Primary Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of uncovered stent struts [ Time Frame: 6 mths post initial PCI procedure ] [ Designated as safety issue: No ]
  • Mean neointimal tissue thickness (microns) [ Time Frame: 6 months post initial PCI Procedure ] [ Designated as safety issue: No ]
  • Stent length (mm) measured using OCT [ Time Frame: 6 months post initial PCI procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT01776567

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

Locations
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 Vascular
Investigators
Principal Investigator: Peter Barlis Northern Hospital
  More Information

No publications provided

Responsible Party: A/Prof. Peter Barlis, Interventional Cardiologist, Northern Hospital, Australia
ClinicalTrials.gov Identifier: NCT01776567     History of Changes
Other Study ID Numbers: 01/12
Study First Received: August 11, 2012
Last Updated: August 2, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Northern Hospital, Australia:
coronary artery disease
stents
optical imaging

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chromium
Cobalt
Everolimus
Sirolimus
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 18, 2014