Mechanism and Predictor of Side Branch Jailing (PRESSURE)

March 28, 2011 updated by: Seoul National University Hospital

Predictor and Mechanism of a Side Branch Jail After Main Branch Stent Implantation in Bifurcation Lesions

Coronary artery bifurcation lesion is still one of the most challenging lesion subsets in the field of non-surgical treatment for a stenotic coronary artery. When one stent is placed in the main brach, it increases the side branch's stenosis degree. However, its mechanism and incidence are not known. This study will be performed to search for the mechanism and incidence of that phenomenon.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with bifurcating coronary artery lesion in left anterior descending coronary artery

Description

Inclusion Criteria:

  1. Elective coronary intervention (including stabilized ACS patients)
  2. Bifurcation lesion with TIMI 3 flow
  3. Side branch diameter > 2mm, side branch lesion length < 10mm by visual estimation

Exclusion Criteria:

  1. Left main coronary disease
  2. AMI, or Old MI at LAD territory
  3. LVEF < 40%, or other significant valvular or myocardial disease
  4. Significant side branch distal lesion
  5. Angiographically visible thrombus
  6. Heavily calcified lesion
  7. Side branch predilatation before main branch stent implantation

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with elective coronary intervention for LAD-diagonal bifurcation lesion with provisional side branch intervention strategy with successful intravascular ultrasound and fractional flow reserve measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Bon-Kwon Koo, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

November 1, 2007

First Submitted That Met QC Criteria

November 1, 2007

First Posted (ESTIMATE)

November 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 30, 2011

Last Update Submitted That Met QC Criteria

March 28, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-0707-022-212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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