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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Prof. Stephen Lee, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01742507
First received: March 22, 2012
Last updated: November 20, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • • OCT derived percentage stent strut coverage at 9 month [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]
    OCT derived percentage stent strut coverage at 9 month


Secondary Outcome Measures:
  • Angiographic binary stenosis [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]
    • Angiographic binary stenosis at 9 month

  • • OCT derived neo-intimal area at 9 month [ Time Frame: at 9 month ] [ Designated as safety issue: Yes ]
    • OCT derived neo-intimal area at 9 month

  • • Minimal lumen diameter by Quantitative Coronary Analysis (QCA) at 9 month [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: Yes ]
    • Target vessel stent thrombosis per Academic Research Consortium (ARC) definition

  • Percentage of stent strut malapposition [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]
    Percentage of stent strut malapposition

  • Mean neo-intimal thickness (NIT) at 9 month [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]
    Mean neo-intimal thickness (NIT) at 9 month

  • Stent volume [ Time Frame: at 9 month ] [ Designated as safety issue: Yes ]
    Stent volume

  • Lumen volume [ Time Frame: at 9 month ] [ Designated as safety issue: Yes ]
    Lumen volume

  • Neointimal Hyperplasia (NIH) volume [ Time Frame: at 9 month ] [ Designated as safety issue: Yes ]
    Neointimal Hyperplasia (NIH) volume


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (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
Other Name: Resolute Integrity Stent
Active Comparator: Biomatrix stent
Biomatrix stent
Device: Biomatrix stent
Biomatrix stent
Other Name: 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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: NCT01742507

Contacts
Contact: Stephen Wai Luen Lee, MD (852) 2255 ext 5409 leewls@ha.org.hk
Contact: Shun Ling Kong, MN,MSc (852) 2255 ext 3597 kongsl@hku.hk

Locations
Hong Kong
Division of Cardiology, Department of Medicine, QMH Recruiting
Hong Kong, Hong Kong
Contact: Shun Ling Kong, MN, MSc    (852) 2255 ext 3597    kongsl@hku.hk   
Sponsors and Collaborators
Prof. Stephen Lee
Investigators
Principal Investigator: Stephen Wai Luen LEE, MD FRCP FACC Queen Mary Hosptial, The Univeristy of Hong Kong
  More Information

No publications provided

Responsible Party: Prof. 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
Study First Received: March 22, 2012
Last Updated: November 20, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on July 13, 2014