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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: without kissing balloon angioplasty "leave alone"; Procedure: kissing balloon

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.

• Study Type: Interventional
• Enrollment (Actual): 504
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • SoonChunHyang University Bucheon Hospital
  • Busan, Korea, Republic of
    • Busan Saint Mary's Hospital
  • Cheongju, Korea, Republic of
    • Cheongju Saint Mary's Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Jinju, Korea, Republic of
    • Kyungsang University 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
    • Hallym University Sacred Heart Hospital
  • Suwon, Korea, Republic of
    • Aju University Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Wonju, Korea, Republic of
    • Kangwon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy	8 month after PCI	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Angiographic reocclusion rate of side branch	8month after PCI	8 months
Angiographic restenosis rate of side branch and the main vessel	8month after PCI	8 months
Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure	8month after PCI	8 months
Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type	8month after PCI	8 months
Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type	8month after PCI	8 months
Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization		2 years
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
Incidence of peri-procedural cardiac enzyme elevation	Day 1 (24 hours after the index procedure)	Day 1
Fluoroscopic time	Day 1 (immediately after the index procedure)	Day 1
Procedure time	Day 1 (immediately after the index procedure)	Day 1
Amount of contrast agent	Day 1 (immediately after the index procedure)	Day 1
Number of used stents	Day 1 (immediately after the index procedure)	Day 1

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 5, 2008
• First Submitted That Met QC Criteria: June 6, 2008
• First Posted (Estimate): June 9, 2008

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: stent; balloon angioplasty; bifurcation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Paclitaxel; Albumin-Bound Paclitaxel; Everolimus; Sirolimus
• Other Study ID Numbers: 2008-0185