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A Study Comparing Two Stent on the Degree of Early Stent Healing and Late Lumen Loss.The OCT-ORION Study (OCT-ORION)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742507
First Posted: December 5, 2012
Last Update Posted: July 26, 2017
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.
Information provided by (Responsible Party):
Professor Stephen Lee, The University of Hong Kong
  Purpose

Stent coverage and neo-intimal growth can be evaluated in-detail by intracoronary optical coherence tomography (OCT), which is a catheter-based imaging technique. It is performed as part of the PCI procedure. OCT is the optical analogue of intravascular ultrasound (IVUS), except that it can provide much higher resolution of coronary cross sectional images than IVUS. The LightLab C7XR OCT system (Frequency Domain OCT) used in this Hospital has obtained full CE Mark, approved by the US FDA, and approved for clinical use in Hong Kong. It has been shown to be safe in clinical settings and has been used in over 300 patients without complication at Queen Mary Hospital.

In this study, stent coverage and neo-intimal growth between zotarolimus-eluting stents (ZES) and biolimus-eluting stents (BES) will be compared by using OCT at 9 month and specific post-intervention re-study intervals.

The investigators objective is to investigate the clinical impact and OCT difference on early stent healing and late lumen loss between the two new-generation limus-eluting-stents - Resolute Integrity and Biomatrix, which differ in stent design, eluting drug and coating polymer.


Condition Intervention Phase
Coronary Artery Disease Device: Resolute Integrity Stent Device: Biomatrix stent Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Optical Coherence Tomography Study Comparing Resolute Integrity to Biomatrix Drug-eluting Stent on the Degree of Early Stent Healing and Late Lumen Loss.The OCT-ORION Study

Further study details as provided by Professor Stephen Lee, The University of Hong Kong:

Primary Outcome Measures:
  • • OCT derived percentage stent strut coverage at 9 month [ Time Frame: 9 month ]
    OCT derived percentage stent strut coverage at 9 month


Secondary Outcome Measures:
  • Angiographic binary stenosis [ Time Frame: 9 month ]
    • Angiographic binary stenosis at 9 month

  • • OCT derived neo-intimal area at 9 month [ Time Frame: at 9 month ]
    • OCT derived neo-intimal area at 9 month

  • • Minimal lumen diameter by Quantitative Coronary Analysis (QCA) at 9 month [ Time Frame: 9 month ]
    • Minimal lumen diameter by Quantitative Coronary Analysis (QCA) at 9 month

  • • All major adverse cardiac events (all cardiac deaths, myocardial infarction, target vessel failure and target lesion revascularization, and stent thrombosis) at the pre-defined 2 to 9 months angiographic and OCT follow-up. [ Time Frame: 2 to 9 months ]
    • All major adverse cardiac events (all cardiac deaths, myocardial infarction, target vessel failure and target lesion revascularization, and stent thrombosis) at the pre-defined 2 to 9 months angiographic and OCT follow-up.

  • • Target vessel stent thrombosis per Academic Research Consortium (ARC) definition [ Time Frame: from enrollment till 2 years follow up ]
    • Target vessel stent thrombosis per Academic Research Consortium (ARC) definition

  • Percentage of stent strut malapposition [ Time Frame: 9 month ]
    Percentage of stent strut malapposition

  • Mean neo-intimal thickness (NIT) at 9 month [ Time Frame: 9 month ]
    Mean neo-intimal thickness (NIT) at 9 month

  • Stent volume [ Time Frame: at 9 month ]
    Stent volume

  • Lumen volume [ Time Frame: at 9 month ]
    Lumen volume

  • Neointimal Hyperplasia (NIH) volume [ Time Frame: at 9 month ]
    Neointimal Hyperplasia (NIH) volume


Enrollment: 60
Study Start Date: April 2012
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Medtronic Resolute Integrity Stent
Medtronic Resolute Integrity Stent
Device: Resolute Integrity Stent
Resolute Integrity Stent
Active Comparator: Biomatrix stent
Biomatrix stent
Device: Biomatrix stent
Biomatrix stent

Detailed Description:

This is a prospective, randomised, assessor-blinded, single centre study. Patients with symptomatic coronary artery diseases in 2 or 3 coronary vessels requiring PCI are eligible for the study. PCI will be performed in the usual manner to all the study lesions in the same procedure. In a randomized fashion, each patient will have one artery with critical disease(s) treated by the Resolute Integrity Stent(s) and the other artery treated by the Biomatrix Stent(s).

Baseline OCT data will be obtained right after stenting. The remaining coronary artery, if diseased and required PCI treatment, will be treated during the angiographic and OCT follow-up as a staged procedure. Patients will be randomly assigned into 5 groups with equal number, receiving a follow-up coronary angiogram with OCT from 2, 3, 4, 5 and 6 months interval post-intervention. Each patient will serve as his/her own control comparing the 2 types of stents. At 9-month post-intervention, all patients will receive a second follow-up coronary angiogram with OCT. All OCT data analyses will be performed in a blinded fashion by a core laboratory. Phone follow up will be carried out for cardiac events at 1 year and 2 year of post intervention.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient aged 18-85 years old
  • Patient with symptomatic coronary artery diseases involving two or more vessels requiring percutaneous coronary intervention

Exclusion Criteria:

  • Patient who is unable to give consent
  • Patient in acute myocardial infarction or unstable angina
  • Patient who is hemodynamically unstable
  • Patient who is allergic to contrast agents
  • Patient who is allergic to anti-platelet agents
  • Patient who is allergic to zotarolimus
  • Patient who is allergic to biolimus
  • Patient who is pregnant
  • Patient who has planned surgery in the following 12 months after percutaneous coronary intervention
  • Left main coronary lesion
  • Bifurcation lesion
  • Chronic total occlusion lesion
  • Coronary vessel size smaller than 2.5mm
  • Coronary lesion longer than 38mm in length
  Contacts and Locations
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): NCT01742507


Locations
Hong Kong
Division of Cardiology, Department of Medicine, QMH
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Stephen Wai Luen LEE, MD FRCP FACC Queen Mary Hosptial, The Univeristy of Hong Kong
  More Information

Publications:

Responsible Party: Professor Stephen Lee, Professor and Chief of Cardiology, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01742507     History of Changes
Other Study ID Numbers: UW 12-093
First Submitted: March 22, 2012
First Posted: December 5, 2012
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Professor Stephen Lee, The University of Hong Kong:
Stent, OCT

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases