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

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:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

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

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:	February 27, 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 May 22, 2013