Coronary Artery DiseaseCROSS-COBISNCT05705362
Simple Crossover Versus Side Branch Opening in Patients With Non-Left Main Bifurcation Lesion
A study testing Simple Crossover and Side branch opening in people with Coronary Artery Disease, run by Keimyung University Dongsan Medical Center.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Simple Crossover and Side branch opening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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
Show all 10Show fewer
- (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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read the detailed 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Simple Crossover, Side branch opening
- Keywords
- Percutaneous coronary intervention, Bifurcation, Treatment strategy, Side branch
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple CrossoverProcedure or surgery
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 openingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Simple crossover arm | Experimental | This arm will receive the main vessel stenting only (with proximal optimization technique). Receives: Procedure: Simple Crossover |
| Side branch opening arm | Active comparator | This arm will receive a side branch opening procedure after the main vessel stenting. Receives: Procedure: Side branch opening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target-lesion failure
a composite of cardiac death, myocardial infarction, and target-lesion revascularization
Measured: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Secondary outcomes (12)
All-cause death
Death from any causes
Measured: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Cardiac death
Death from cardiac causes
Measured: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Myocardial infarction
any myocardial infarction
Measured: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Target-vessel myocardial infarction
myocardial infarction in target-vessel
Measured: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Target-lesion revascularization
Clinically indicated target-lesion revascularization
Measured: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Target-vessel revascularization
Clinically indicated target-vessel revascularization
Measured: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Any revascularization
Repeat revascularization procedure
Measured: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Stent thrombosis
definite or probable stent thrombosis by Academic Research Consortium [ARC] definition
Measured: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Bleeding
Bleeding ARC type 2, 3 or 5 bleeding
Measured: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Total procedure time
procedure time
Measured: at 1 day
Total amount of contrast use
used contrast amount
Measured: at 1 day
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
Measured: 72 hours after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAM, Chang-Wook, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705362
- Sponsor's protocol ID
- CROSS-COBIS
- Acronym
- CROSS-COBIS
- Status last verified
- Jan 2023
- First submitted
- 19 Dec 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05705362
- Acronym / sponsor ID
- CROSS-COBIS / CROSS-COBIS
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous coronary intervention, Bifurcation, Treatment strategy, Side branch
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple crossover arm | Experimental | Procedure: Simple CrossoverThis arm will receive the main vessel stenting only (with proximal optimization technique). |
| Side branch opening arm | Active comparator | Procedure: Side branch openingThis arm will receive a side branch opening procedure after the main vessel stenting. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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
Key exclusion criteria (10 listed)
- (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)*
- (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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple CrossoverRegardless 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. | Procedure or surgery | Simple crossover arm |
| Side branch openingAccording 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. | Procedure or surgery | Side branch opening arm |
Primary outcome
Target-lesion failure
Time frame: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
a composite of cardiac death, myocardial infarction, and target-lesion revascularization
12 secondary outcomes
All-cause death
Time frame: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Cardiac death
Time frame: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Myocardial infarction
Time frame: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Target-vessel myocardial infarction
Time frame: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Target-lesion revascularization
Time frame: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Target-vessel revascularization
Time frame: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Any revascularization
Time frame: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Stent thrombosis
Time frame: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Bleeding
Time frame: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
Total procedure time
Time frame: at 1 day
Total amount of contrast use
Time frame: at 1 day
Incidence of contrast induced nephropathy
Time frame: 72 hours after the index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Simple Crossover and Side branch opening in people with Coronary Artery Disease, run by Keimyung University Dongsan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang-Wook Nam, MD (82-53-258-7019, namcwcv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target-lesion failure (time frame: up to 2 years of median follow-up (till 1 year after the last patient enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.