Simple Crossover Versus Side Branch Opening in Patients With Non-Left Main Bifurcation Lesion

Coronary Artery Disease Clinical Trial

— CROSS-COBIS  

Official title:

Randomized Controlled Trial of Simple CROSSsover Versus Side Branch Opening on Clinical Outcomes in Patients With Non-Left Main BIfurcation LeSion (CROSS-COBIS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05705362
• Other study ID #: CROSS-COBIS
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: January 2023
• Source: Keimyung University Dongsan Medical Center
• Contact: Chang-Wook Nam, MD
• Phone: 82-53-258-7019
• Email: namcwcv[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Despite advances in stenting techniques and devices, percutaneous coronary intervention (PCI) for bifurcation lesions remains one of the most challenging and complex procedures. Current guidelines recommend 1-stenting with provisional side branch (SB) approach should be an initial treatment strategy for the bifurcation lesions, based on the previous results of several randomized trials. However, the standardization of the provisional strategy is limited. In particular, there is a recommendation on the treatment technique for SB when SB intervention is required, but It has not been decided in which cases SB treatment is necessary, in the latest European Bifurcation Club (EBC) consensus document.16 In previous studies, the criteria for performing SB opening after MV stent intervention in the 1-stenting with provisional SB approach were varied. In the DK-CUSH II (Double Kissing Crush versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions) or CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) trials, SB intervention was performed when the SB diameter stenosis more than 50%, grade B or higher dissection, or blood flow disturbance (TIMI flow 2 or less) after MV stent insertion. On the other hand, in the Nordic trial, the authors applied strict criteria for SB intervention after MV stent insertion (TIMI flow 2 or less only). Furthermore, there have been conflicting results regarding the clinical and angiographic outcomes of the jailed SB opening strategy after the main vessel (MV) stenting, compared with the simple crossover strategy for non-left main bifurcation lesion. On this background, this trial aims to compare the clinical outcomes between simple crossover and side branch opening strategies in patients with the angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2029
• Est. primary completion date: March 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• (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

Exclusion Criteria:

• (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)*

1. Reduced SB TIMI flow (=2) after MV stenting

2. 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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Simple Crossover
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.
• Side branch opening
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause death	Death from any causes	up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Secondary	Cardiac death	Death from cardiac causes	up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Secondary	Myocardial infarction	any myocardial infarction	up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Secondary	Target-vessel myocardial infarction	myocardial infarction in target-vessel	up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Secondary	Target-lesion revascularization	Clinically indicated target-lesion revascularization	up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Secondary	Target-vessel revascularization	Clinically indicated target-vessel revascularization	up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Secondary	Any revascularization	Repeat revascularization procedure	up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Secondary	Stent thrombosis	definite or probable stent thrombosis by Academic Research Consortium [ARC] definition	up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Secondary	Bleeding	Bleeding ARC type 2, 3 or 5 bleeding	up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Secondary	Total procedure time	procedure time	at 1 day
Secondary	Total amount of contrast use	used contrast amount	at 1 day
Secondary	Incidence of contrast induced nephropathy	defined as an increase in creatinine of =0.5mg/dL or =25% from baseline within 72 hours after contrast exposure	72 hours after the index procedure