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Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch (CROSS)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
kissing balloon
without kissing balloon angioplasty "leave alone"
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring stent, bifurcation, balloon angioplasty

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Soonchunhyang University Bucheon Hospital
  • Busan Saint Mary's Hospital
  • Cheongju Saint Mary's Hospital
  • Chungnam National University Hospital
  • Kyungsang University Hospital
  • Hallym University Sacred Heart Hospital
  • Catholic University, Kangnam St. Mary's Hospital
  • Hallym University Sacred Heart Hospital
  • Aju University Hospital
  • Ulsan University Hospital
  • Kangwon University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

bifurcation stent techniqe

bifurcation stent technique

Arm Description

cross over stenting without kissing balloon angioplasty "leave alone"

kissing balloon angioplasty

Outcomes

Primary Outcome Measures

Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy
8 month after PCI

Secondary Outcome Measures

Incidence of side branch jail after main vessel stenting according to the stent type used
Day 1 (24 hours after the index procedure)
Angiographic reocclusion rate of side branch
8month after PCI
Angiographic restenosis rate of side branch and the main vessel
8month after PCI
Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure
8month after PCI
Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type
8month after PCI
Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type
8month after PCI
Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization
FFR of the side branch at post-procedure and at follow-up
Day 1 (immediately after the index procedure)and 8month after PCI
Incidence of peri-procedural cardiac enzyme elevation
Day 1 (24 hours after the index procedure)
Fluoroscopic time
Day 1 (immediately after the index procedure)
Procedure time
Day 1 (immediately after the index procedure)
Amount of contrast agent
Day 1 (immediately after the index procedure)
Number of used stents
Day 1 (immediately after the index procedure)

Full Information

First Posted
June 5, 2008
Last Updated
November 17, 2015
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00694005
Brief Title
Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch
Acronym
CROSS
Official Title
Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
stent, bifurcation, balloon angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bifurcation stent techniqe
Arm Type
Active Comparator
Arm Description
cross over stenting without kissing balloon angioplasty "leave alone"
Arm Title
bifurcation stent technique
Arm Type
Experimental
Arm Description
kissing balloon angioplasty
Intervention Type
Procedure
Intervention Name(s)
kissing balloon
Other Intervention Name(s)
Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents
Intervention Description
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
Intervention Type
Procedure
Intervention Name(s)
without kissing balloon angioplasty "leave alone"
Other Intervention Name(s)
sirolimus, zotarolimus, paclitaxel, and everolimus stents
Intervention Description
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
Primary Outcome Measure Information:
Title
Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy
Description
8 month after PCI
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Incidence of side branch jail after main vessel stenting according to the stent type used
Description
Day 1 (24 hours after the index procedure)
Time Frame
Day 1
Title
Angiographic reocclusion rate of side branch
Description
8month after PCI
Time Frame
8 months
Title
Angiographic restenosis rate of side branch and the main vessel
Description
8month after PCI
Time Frame
8 months
Title
Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure
Description
8month after PCI
Time Frame
8 months
Title
Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type
Description
8month after PCI
Time Frame
8 months
Title
Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type
Description
8month after PCI
Time Frame
8 months
Title
Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization
Time Frame
2 years
Title
FFR of the side branch at post-procedure and at follow-up
Description
Day 1 (immediately after the index procedure)and 8month after PCI
Time Frame
Day 1, 8 months
Title
Incidence of peri-procedural cardiac enzyme elevation
Description
Day 1 (24 hours after the index procedure)
Time Frame
Day 1
Title
Fluoroscopic time
Description
Day 1 (immediately after the index procedure)
Time Frame
Day 1
Title
Procedure time
Description
Day 1 (immediately after the index procedure)
Time Frame
Day 1
Title
Amount of contrast agent
Description
Day 1 (immediately after the index procedure)
Time Frame
Day 1
Title
Number of used stents
Description
Day 1 (immediately after the index procedure)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Busan Saint Mary's Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Cheongju Saint Mary's Hospital
City
Cheongju
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Kyungsang University Hospital
City
Jinju
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
PyeongChon
Country
Korea, Republic of
Facility Name
Catholic University, Kangnam St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Aju University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Kangwon University Hospital
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

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Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch

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