Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch
CROSS
Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch
1 other identifier
interventional
504
1 country
11
Brief Summary
Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Jan 2008
Longer than P75 for phase_4 coronary-artery-disease
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 5, 2008
CompletedFirst Posted
Study publicly available on registry
June 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedNovember 20, 2015
November 1, 2015
7 years
June 5, 2008
November 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy
8 month after PCI
8 months
Secondary Outcomes (13)
Incidence of side branch jail after main vessel stenting according to the stent type used
Day 1
Angiographic reocclusion rate of side branch
8 months
Angiographic restenosis rate of side branch and the main vessel
8 months
Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure
8 months
Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type
8 months
- +8 more secondary outcomes
Study Arms (2)
bifurcation stent techniqe
ACTIVE COMPARATORcross over stenting without kissing balloon angioplasty "leave alone"
bifurcation stent technique
EXPERIMENTALkissing balloon angioplasty
Interventions
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (11)
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Busan Saint Mary's Hospital
Busan, South Korea
Cheongju Saint Mary's Hospital
Cheongju-si, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Kyungsang University Hospital
Jinju, South Korea
Hallym University Sacred Heart Hospital
Pyeongchon, South Korea
Catholic University, Kangnam St. Mary's Hospital
Seoul, South Korea
Hallym University Sacred Heart Hospital
Seoul, South Korea
Aju University Hospital
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea
Kangwon University Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD, PhD
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
Study Record Dates
First Submitted
June 5, 2008
First Posted
June 9, 2008
Study Start
January 1, 2008
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
November 20, 2015
Record last verified: 2015-11