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

NCT01742507 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-07-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Resolute Integrity Stent

Resolute Integrity Stent

DEVICE

Biomatrix stent

Biomatrix stent

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Stephen Wai Luen LEE, MD FRCP FACC · Queen Mary Hosptial, The Univeristy of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01742507 on ClinicalTrials.gov