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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Everolimus eluting stents

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Peter Barlis, MBBS MPH PHD FESC FRACP; Phone Number: +61 3 8405 8554; Email: pbarlis@unimelb.edu.au

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• 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	Immediately following stent deployment

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of uncovered stent struts	6 mths post initial PCI procedure
Mean neointimal tissue thickness (microns)	6 months post initial PCI Procedure
Stent length (mm) measured using OCT	6 months post initial PCI procedure

Collaborators and Investigators

• Sponsor: Northern Hospital, Australia
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Peter Barlis, Northern Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: August 11, 2012
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 28, 2013

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 2, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: coronary artery disease; stents; optical imaging
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: 01/12