NCT01776567

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jul 2012

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

2.4 years

First QC Date

August 11, 2012

Last Update Submit

August 2, 2014

Conditions

Coronary Artery Disease

Keywords

coronary artery diseasestentsoptical imaging

Outcome Measures

Primary Outcomes (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

    Immediately following stent deployment

Secondary Outcomes (3)

  • 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

Study Arms (2)

Cobalt Chromium Everolimus-eluting stent (Xience Prime)

ACTIVE COMPARATOR

Cobalt Chromium Everolimus-eluting stent (Xience Prime)

Device: Everolimus eluting stents

Platinum Chromium Everolimus-eluting stent (Promus Element)

ACTIVE COMPARATOR

Platinum Chromium Everolimus-eluting stent (Promus Element)

Device: Everolimus eluting stents

Interventions

Everolimus eluting stentsDEVICE
Cobalt Chromium Everolimus-eluting stent (Xience Prime)Platinum Chromium Everolimus-eluting stent (Promus Element)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 4.25 mm which can be covered with one or multiple stents
  • No limitation to the number of treated lesions or number of vessels according to the randomization group
  • 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

You may not qualify if:

  • Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, platinum chromium, everolimus, contrast material
  • Acute ST-segment elevation myocardial infarction
  • Type A lesion including vessel angulation \<45 degrees
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Concord Repatriation Hospital

Concord, New South Wales, Australia

NOT YET RECRUITING

The Prince Charles Hospital

Brisbane, Queensland, Australia

NOT YET RECRUITING

Northern Hospital

Epping, Victoria, 3076, Australia

RECRUITING

St Vincent's Hospital

Melbourne, Victoria, 3065, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Peter Barlis

    Northern Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Barlis, MBBS MPH PHD FESC FRACP

CONTACT

+61 3 8405 8554pbarlis@unimelb.edu.au

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

August 11, 2012

First Posted

January 28, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

AU(4)