Mechanism and Predictor of Side Branch Jailing - Full Text View

Mechanism and Predictor of Side Branch Jailing (PRESSURE)

This study is currently recruiting participants.
Verified by Seoul National University Hospital, December 2007

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00553670

Purpose

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.

Condition

Bifurcating Coronary Artery Lesions
Main Branch Stent Implantation
Side Branch Jailing

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

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

Further study details as provided by Seoul National University Hospital:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2008

Groups/Cohorts

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553670

Contacts


Contact: Bon-Kwon Koo, PhD	82-2-2072-2677	bkkoo@snu.ac.kr

Contact: Hyun-Jai Kang, PhD	82-2-2072-3757	nowkang@medimail.co.kr

Locations


Korea, Republic of
	Seoul national university hospital	Recruiting
	Seoul, Korea, Republic of, 110744

Sponsors and Collaborators

Seoul National University Hospital

Investigators


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

More Information

Study ID Numbers:	H-0707-022-212
First Received:	November 1, 2007
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00553670
Health Authority:	Korea: Food and Drug admministration

Keywords provided by Seoul National University Hospital:

coronary artery

bifurcation

stent

intravascular ultrasound

fractional flow reserve

ClinicalTrials.gov processed this record on October 07, 2008