Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch - Full Text View

Sponsored by:	CardioVascular Research Foundation, Korea
Information provided by:	CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:	NCT00694005

Purpose

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

MedlinePlus related topics: Angioplasty Coronary Artery Disease

U.S. FDA Resources

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

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:

Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The rate of angiographic reocclusion, restenosis, death, myocardial infarction, target lesion revascularization [ Time Frame: 8-12 months ] [ Designated as safety issue: Yes ]

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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical
- Patients with angina and documented ischemia or patients with documented silent ischemia
- Patients who are eligible for intracoronary stenting
- Age >18 years, <75 ages
Angiographic
- De novo lesion located in a major bifurcation point with the MEDINA classification type 1.1.0, 1.0.0, or 0.1.0
- Main vessel : > 2.5 mm in vessel size, > 50% in diameter stenosis and < 50 mm in lesion length by visual estimation, in which the lesion is covered with < 2 stents
- Side branch :> 2.0 mm in vessel size and < 50% diameter stenosis by visual estimation

Exclusion Criteria:

History of bleeding diathesis or coagulopathy
Pregnant
Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus, paclitaxel and zotarolimus
Limited life-expectancy (less than 1 year) due to combined serious disease
ST-elevation acute myocardial infarction < 2 weeks
Characteristics of lesion:
- Left main disease
- In-stent restenosis
- Graft vessels
- TIMI flow < grade 2 in the side branch
- Chronic total occlusion
- Renal dysfunction, creatinine > 2.0mg/dL
- Contraindication to aspirin, clopidogrel or cilostazol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694005

Contacts

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

Locations

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

Sponsors and Collaborators

CardioVascular Research Foundation, Korea

Investigators

Principal Investigator:

Seung-Jung Park, MD, PhD

Asan Medical Center

More Information

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)

Keywords provided by CardioVascular Research Foundation, Korea:

stent
bifurcation
balloon angioplasty

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009