MedDataX Logo

Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch

NCT ID: NCT00694005

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

bifurcation stent techniqe

cross over stenting without kissing balloon angioplasty "leave alone"

Group Type ACTIVE_COMPARATOR

without kissing balloon angioplasty "leave alone"

Intervention Type PROCEDURE

simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions

bifurcation stent technique

kissing balloon angioplasty

Group Type EXPERIMENTAL

kissing balloon

Intervention Type PROCEDURE

simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

kissing balloon

simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions

Intervention Type PROCEDURE

without kissing balloon angioplasty "leave alone"

simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents sirolimus, zotarolimus, paclitaxel, and everolimus stents

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Soonchunhyang University Bucheon Hospital

Bucheon-si, , South Korea

Site Status

Busan Saint Mary's Hospital

Busan, , South Korea

Site Status

Cheongju Saint Mary's Hospital

Cheongju-si, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Kyungsang University Hospital

Jinju, , South Korea

Site Status

Hallym University Sacred Heart Hospital

Pyeongchon, , South Korea

Site Status

Catholic University, Kangnam St. Mary's Hospital

Seoul, , South Korea

Site Status

Hallym University Sacred Heart Hospital

Seoul, , South Korea

Site Status

Aju University Hospital

Suwon, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Kangwon University Hospital

Wŏnju, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-0185

Identifier Type: -

Identifier Source: org_study_id