Completed

Angiographic and IVUS Criteria Defining Physiologic Optimization By the Fractional Flow Reserve After DES Implantation

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

From 20 to 85 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: March 2010
See protocol details

Summary

Principal SponsorInje University
Last updated: March 24, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2010

Actual date on which the first participant was enrolled.

Invasive imaging criteria of the Coronary arteriography (CAG) and intravascular ultrasound imaging (IVUS), satisfying procedural optimization after drug eluting stent (DES) implantation, were used in < 10% DS by CAG and 5-5.5mm2 MSA by IVUS. Whether these criteria satisfy not only relieving visible stenosis but also relieving lesion specific ischemia or not were unclear. Fractional flow reserve (FFR), an index of lesion specific ischemia, was proposed 0.9 as a physiologic criteria satisfying successful stent implantation by previous studies with bare metal stent. FFR after drug-eluting stent implantation can be an useful predictor for clinical outcome. But, direct comparative evaluation of the invasive imaging criteria defining as an indicator relieving myocardial ischemia were not reported. The aim of this study was to investigate angiographic and IVUS parameters in which corresponding FFR and evaluate their optimal physiologic criteria after DES implantation.

NCT01667757
Principal SponsorInje University
Last updated: March 24, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesHeart DiseasesVascular DiseasesMyocardial IschemiaCoronary Artery DiseaseCoronary Disease

Criteria

4 inclusion criteria required to participate
At least one segment of three major epicardial coronary arteries were consecutively enrolled in invasive CAG
Post- stent FFR and IVUS measurement performed at the immediately after whole PCI procedures
agree with informed consent
clinical angina pectoris who underwent IVUS and FFR during coronary angiography and after DES implantation
5 exclusion criteria prevent from participating
acute myocardial infarction related coronary artery
allergy to adenosine injection
chronic renal failure (Cr > 2.0mg/dl)
low left ventricular ejection fraction less than 35%
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Inje University Ilsan Paik Hospital

Goyang, South KoreaOpen Inje University Ilsan Paik Hospital in Google Maps
CompletedOne Study Center