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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00694005
First received: June 5, 2008
Last updated: August 20, 2014
Last verified: August 2014
  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
Procedure: without kissing balloon angioplasty "leave alone"
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch

Resource links provided by NLM:


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 ]
    8 month after PCI


Secondary Outcome Measures:
  • Incidence of side branch jail after main vessel stenting according to the stent type used [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 (24 hours after the index procedure)

  • Angiographic reocclusion rate of side branch [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    8month after PCI

  • Angiographic restenosis rate of side branch and the main vessel [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    8month after PCI

  • Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    8month after PCI

  • Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    8month after PCI

  • Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    8month after PCI

  • Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • FFR of the side branch at post-procedure and at follow-up [ Time Frame: Day 1, 8 months ] [ Designated as safety issue: No ]
    Day 1 (immediately after the index procedure)and 8month after PCI

  • Incidence of peri-procedural cardiac enzyme elevation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 (24 hours after the index procedure)

  • Fluoroscopic time [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 (immediately after the index procedure)

  • Procedure time [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 (immediately after the index procedure)

  • Amount of contrast agent [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 (immediately after the index procedure)

  • Number of used stents [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 (immediately after the index procedure)


Estimated Enrollment: 600
Study Start Date: January 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bifurcation stent techniqe
cross over stenting without kissing balloon angioplasty "leave alone"
Procedure: without kissing balloon angioplasty "leave alone"
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
Other Name: sirolimus, zotarolimus, paclitaxel, and everolimus stents
Experimental: bifurcation stent technique
kissing balloon angioplasty
Procedure: kissing balloon
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
Other Name: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Hallym University Sacred Heart Hospital
Seoul, Korea, Republic of
Catholic University, Kangnam St. Mary's Hospital
Seoul, Korea, Republic of
Aju University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Kangwon University Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00694005     History of Changes
Other Study ID Numbers: 2008-0185
Study First Received: June 5, 2008
Last Updated: August 20, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
stent
bifurcation
balloon angioplasty

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Sirolimus
Everolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on September 22, 2014