Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
CardioVascular Research Foundation, Korea |
---|---|
Information provided by: | CardioVascular Research Foundation, Korea |
ClinicalTrials.gov Identifier: | NCT00694005 |
Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Procedure: kissing balloon angioplasty |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch |
Estimated Enrollment: | 180 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
without kissing balloon angioplasty "leave alone"
|
Procedure: kissing balloon angioplasty
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
|
2: Experimental
kissing balloon angioplasty
|
Procedure: kissing balloon angioplasty
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
|
Among the bifurcation type, bifurcation lesion without significant side branch stenosis (<50%) usually did not require side branch stenting, but owing to several putative mechanism including dissection, thrombosis formation, embolization of plaque debris, ostial compromise by displaced stent strut, and snow plow effect, the side branch might be compromised. In this situation, the strategy to achieve optimal results has not been reported. Recently, FFR study showed that most jailed side branch (vessel size >2.0 mm. DS>50%) after main branch stenting did not have functional significance. We compared strategies with or without routine kissing balloon dilatation for less than 50% stenosis after simple DES crossing for bifurcation lesions (bifurcation type 1.1.0, 1.0.0, and 0.1.0 according to Medina classification) with serial change of FFR measurement.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical
Angiographic
Exclusion Criteria:
Characteristics of lesion:
Contact: Young-Hak Kim, MD, PhD | 82-2-3010-3955 | mdyhkim@amc.seoul.kr |
Contact: Duk-Woo Park, MD | 82-2-3010-3995 | parkdukwoo@hanmail.net |
Korea, Republic of | |
Aju University Hospital | Recruiting |
Suwon, Korea, Republic of | |
Contact: Seung-Jea Tahk, MD, PhD sjtahk@ajou.ac.kr | |
Principal Investigator: Seung-Jea Tahk, MD | |
Busan Saint Mary's Hospital | Recruiting |
Busan, Korea, Republic of | |
Contact: Jae-Sik Jang jsjang@medimail.co.kr | |
Catholic University, Kangnam St. Mary's Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Ki-Bae Seung kbseung@catholic.ac.kr | |
Chungju Saint Mary's Hospital | Recruiting |
Chungju, Korea, Republic of | |
Contact: Yong-Mo Yang ymyang67@yahoo.co.kr | |
Chungnam National University Hospital | Recruiting |
Daejeon, Korea, Republic of | |
Contact: In-Whan Seong iwseong@cnu.ac.kr | |
Ulsan University Hospital | Recruiting |
Ulsan, Korea, Republic of | |
Contact: Sang-Gon Lee sglee@uuh.ulsan.kr | |
Hallym University Sacred Heart Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Min-Gyu Kim cagkim@hanmail.net | |
Kangwon University Hospital | Recruiting |
Wonju, Korea, Republic of | |
Contact: Bong-Ki Lee nicedr@nate.com | |
Kyungsang University Hospital | Recruiting |
Jinju, Korea, Republic of | |
Contact: Bong-Ryong Choi choibr7@naver.com | |
Soonchunhyang University Bucheon Hospital | Recruiting |
Bucheon, Korea, Republic of | |
Contact: Nae-Hee Lee naeheelee@naver.com | |
Hallym University Sacred Heart Hospital | Recruiting |
PyeongChon, Korea, Republic of | |
Contact: Young-Jin Choi cyj@hallym.ac.kr |
Principal Investigator: | Seung-Jung Park, MD, PhD | Asan Medical Center |
Responsible Party: | Asan Meeical Center, University of Ulsan College of Medicine ( Seung-Jung Park ) |
Study ID Numbers: | 2008-0185 |
Study First Received: | June 5, 2008 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00694005 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
stent bifurcation balloon angioplasty |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |