Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch

Coronary Artery Disease Clinical Trial

— CROSS  

Official title:

Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694005
• Other study ID #: 2008-0185
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2008
• Last updated: November 17, 2015
• Start date: January 2008
• Est. completion date: January 2015

Study information

• Verified date: November 2015
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• kissing balloon
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
• without kissing balloon angioplasty "leave alone"
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Busan Saint Mary's Hospital	Busan
Korea, Republic of	Cheongju Saint Mary's Hospital	Cheongju
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Kyungsang University Hospital	Jinju
Korea, Republic of	Hallym University Sacred Heart Hospital	PyeongChon
Korea, Republic of	Catholic University, Kangnam St. Mary's Hospital	Seoul
Korea, Republic of	Hallym University Sacred Heart Hospital	Seoul
Korea, Republic of	Aju University Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Kangwon University Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy	8 month after PCI	8 months	No
Secondary	Incidence of side branch jail after main vessel stenting according to the stent type used	Day 1 (24 hours after the index procedure)	Day 1	No
Secondary	Angiographic reocclusion rate of side branch	8month after PCI	8 months	No
Secondary	Angiographic restenosis rate of side branch and the main vessel	8month after PCI	8 months	No
Secondary	Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure	8month after PCI	8 months	No
Secondary	Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type	8month after PCI	8 months	No
Secondary	Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type	8month after PCI	8 months	No
Secondary	Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization		2 years	Yes
Secondary	FFR of the side branch at post-procedure and at follow-up	Day 1 (immediately after the index procedure)and 8month after PCI	Day 1, 8 months	No
Secondary	Incidence of peri-procedural cardiac enzyme elevation	Day 1 (24 hours after the index procedure)	Day 1	No
Secondary	Fluoroscopic time	Day 1 (immediately after the index procedure)	Day 1	No
Secondary	Procedure time	Day 1 (immediately after the index procedure)	Day 1	No
Secondary	Amount of contrast agent	Day 1 (immediately after the index procedure)	Day 1	No
Secondary	Number of used stents	Day 1 (immediately after the index procedure)	Day 1	No