Simple Crossover Versus Side Branch Opening in Patients With Non-Left Main Bifurcation Lesion
CROSS-COBIS
Randomized Controlled Trial of Simple CROSSsover Versus Side Branch Opening on Clinical Outcomes in Patients With Non-Left Main BIfurcation LeSion (CROSS-COBIS)
1 other identifier
interventional
1,000
0 countries
N/A
Brief Summary
Hypothesis: Simple crossover strategy would be non-inferior to SB opening strategy in the risk of target lesion failure (TLF) in patients with angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion. A total of 1000 patients (500 per each group) with the angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion will be enrolled. Patients will be randomized to either the simple crossover strategy group or SB opening strategy group at the time of enrollment with 1:1 ratio. Stratified randomization according to participating center, clinical presentation (acute coronary syndrome or stable ischemic heart disease), and type of bifurcation lesions (true or non-true) will be performed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Mar 2023
Longer than P75 for not_applicable coronary-artery-disease
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
First Submitted
Initial submission to the registry
December 19, 2022
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
January 30, 2023
January 1, 2023
5.1 years
December 19, 2022
January 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target-lesion failure
a composite of cardiac death, myocardial infarction, and target-lesion revascularization
up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Secondary Outcomes (12)
All-cause death
up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Cardiac death
up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Myocardial infarction
up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Target-vessel myocardial infarction
up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Target-lesion revascularization
up to 2 years of median follow-up (till 1 year after the last patient enrollment)
- +7 more secondary outcomes
Study Arms (2)
Simple crossover arm
EXPERIMENTALThis arm will receive the main vessel stenting only (with proximal optimization technique).
Side branch opening arm
ACTIVE COMPARATORThis arm will receive a side branch opening procedure after the main vessel stenting.
Interventions
Regardless of allocated arms, stent implantation in the MV (selected 1:1 according to the distal MV size) followed by systematic proximal optimization technique (POT, post-dilatation of the stent at the level of proximal MV with a balloon diameter sized 1:1 according to the proximal MV) or POT like procedure is strongly recommended.
According to the latest European Bifurcation Club (EBC) consensus document, distal SB rewiring followed by kissing balloon inflation (eventually conducted with short non-compliant balloons) and repeat POT procedures are highly recommended. An additional stent will be allowed if major dissection or decreased TIMI flow of SB occurs during SB treatment.
Eligibility Criteria
You may qualify if:
- (1) Subject must be at least 19 years of age
- (2) Patients with non-left main bifurcation lesion (SB diameter ≥2.3 mm)
- (3) Target lesions amenable for 1-stenting with provisional SB approach by operators' decision
- (4) Angiographically compromised SB (visual SB stenosis ≥50%) after provisional MV stenting
You may not qualify if:
- (1) Target lesions requiring elective 2-stenting technique by operators' decision (Observation Group 1)\*
- (2) Patients who inevitably require SB intervention after MV stenting, as follows. (Observation Group 2)\*
- Reduced SB TIMI flow (≤2) after MV stenting
- SB dissection after MV stenting (≥ Type C)
- (3) Patients without SB compromise after MV stenting (visually SB stenosis \<50%) (Observation Group 3)\*
- (4) Cardiogenic shock (Killip class IV) at presentation
- (5) Patients with significant valvular heart disease or severe left ventricular systolic dysfunction (ejection fraction \<35%)
- (6) Pregnancy or breast feeding
- (7) Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- (8) Unwillingness or inability to comply with the procedures described in this protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 19, 2022
First Posted
January 30, 2023
Study Start
March 1, 2023
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
January 30, 2023
Record last verified: 2023-01