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NCT Number: NCT01742507

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

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.

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Key information

Conditions

Coronary Artery Disease Amino Acid Metabolism, Inborn Errors Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Disease Genetic Diseases, Inborn Genetic Diseases, X-Linked Heart Diseases Metabolic Diseases Metabolism, Inborn Errors Myocardial Ischemia Nervous System Diseases Nutritional and Metabolic Diseases Ornithine Carbamoyltransferase Deficiency Disease Urea Cycle Disorders, Inborn Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology, Department of Medicine, QMH

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resolute Integrity Stent

Device

Resolute Integrity Stent

Biomatrix stent

Device

Biomatrix stent

Primary outcomes

  1. • OCT derived percentage stent strut coverage at 9 month

    Time frame: 9 month

    OCT derived percentage stent strut coverage at 9 month

Secondary outcomes

  1. Angiographic binary stenosis

    Time frame: 9 month

    • Angiographic binary stenosis at 9 month

  2. • OCT derived neo-intimal area at 9 month

    Time frame: at 9 month

    • OCT derived neo-intimal area at 9 month

  3. • 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

  4. • 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.

  5. • 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

  6. Percentage of stent strut malapposition

    Time frame: 9 month

    Percentage of stent strut malapposition

  7. Mean neo-intimal thickness (NIT) at 9 month

    Time frame: 9 month

    Mean neo-intimal thickness (NIT) at 9 month

  8. Stent volume

    Time frame: at 9 month

    Stent volume

  9. Lumen volume

    Time frame: at 9 month

    Lumen volume

  10. Neointimal Hyperplasia (NIH) volume

    Time frame: at 9 month

    Neointimal Hyperplasia (NIH) volume

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Acronym: OCT-ORION

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2012
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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