PROVISIONDEB: Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.

Sponsor

Saint Vincent's Hospital, Korea (Other)

Overall Status

Recruiting

CT.gov ID

NCT06002932

Collaborator

(none)

750

Enrollment

Location

Arms

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

[The Purpose of the Clinical Study] The purpose of this randomized comparison study is to compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients with non-LM coronary true-bifurcation lesions.

[Hypothesis] In this study, the researchers intend to verify the hypothesis that the 1-stent strategy with a drug-eluting balloon is non-inferior to the 2-stent strategy in terms of target lesion failures (cardiac death, target vessel MI, or target vessel revascularization).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Ischemic Heart Disease	Procedure: Procedure: planed 2-stent strategy Procedure: Procedure: provisional 1-stent plus DEB strategy	N/A

Detailed Description

Provisional 1-stent plus DEB strategy As a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branch vessel. The order of the treatments done to the main vessel and the branch vessel shall be at the discretion of the treatment provider. Also, at the discretion of the treatment provider, a bail-out stenting can still be performed, depending on the condition of the branch vessel following a drug-eluting balloon treatment. However, bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or significant residual stenosis.
Planned 2-stent strategy As per the conventional treatment process, this strategy treats both the main vessel and the branch vessel with stents. The decision among Crush (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the treatment provider.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

InterventionIntervention

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of PROVISIONal 1-stent Strategy With Drug-Eluting Balloon Versus Planned 2-stent Strategy in Patients With Non-LM Coronary True-Bifurcation Lesions.

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2028

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional arm As per the conventional treatment process, this strategy treats both the main vessel and the branch vessel with stents. The decision among Crush (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the treatment provider.	Procedure: Procedure: planed 2-stent strategy Procedure: planed 2-stent strategy
Experimental: PROVISION-DEB arm As a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branch vessel. The order of the treatments done to the main vessel and the branch vessel shall be at the discretion of the treatment provider. Also, at the discretion of the treatment provider, a bail-out stenting can still be performed, depending on the condition of the branch vessel following a drug-eluting balloon treatment. However, bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or significant residual stenosis.	Procedure: Procedure: provisional 1-stent plus DEB strategy Procedure: provisional 1-stent plus DEB strategy

Arm

Intervention/Treatment

Active Comparator: Conventional arm

As per the conventional treatment process, this strategy treats both the main vessel and the branch vessel with stents. The decision among Crush (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the treatment provider.

Procedure: Procedure: planed 2-stent strategy

Procedure: planed 2-stent strategy

Experimental: PROVISION-DEB arm

As a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branch vessel. The order of the treatments done to the main vessel and the branch vessel shall be at the discretion of the treatment provider. Also, at the discretion of the treatment provider, a bail-out stenting can still be performed, depending on the condition of the branch vessel following a drug-eluting balloon treatment. However, bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or significant residual stenosis.

Procedure: Procedure: provisional 1-stent plus DEB strategy

Procedure: provisional 1-stent plus DEB strategy

Outcome Measures

Primary Outcome Measures

target lesion failure the number of events [12 months after randomization]
composite outcomes the number of events (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

① 19+ years old

② Patients with the following lesions and clinical factors. 2-1. The lesion factor: Visually confirmed diameter of the 2.25-2.75 mm in branched vessels, where the main blood vessel's diameter is at least 2.5 mm; the lesion at the branched vessels is of a Medina classification (1,1,1), (1,0,1), or (0,1,1), with a true bifurcation; a de novo lesion.

2-2 Clinical factors: Stable angina pectoris, unstable angina pectoris, or myocardial infarction with an elevated non-ST segment, all at least 24 hours after their last treatment.

③ Patients who understood the definitions of the test group and the control group and the risks involved in the treatment, and with voluntary, informed consent to participate in the study, as provided either by the patient or their legal representatives.

Exclusion Criteria:

Patients with myocardial infarction involving an elevated ST segment, or patients with an LM coronary true-bifurcation lesion.
Patients who are ruled out by the treatment provider because the 2-stent strategy was deemed unsuitable to the patient due to a clinical condition.
A patient with aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel) contraindications.
A patient who experienced psychogenic shock at the time of admission, or showed severe left ventricle insufficiency (where the left ventricle ejection fraction is less than 30%.)
A patient who requires prolonged anti-coagulative treatment (warfarin or a new oral anti-coagulant [NOAC])
A patient who is currently hemorrhagic, or has a high risk of major hemorrhage (active peptic ulcer, GI lesions with high hemorrhagic risks, malicious tumors with a high risk of hemorrhage) ⑦ A patient with a history of intra-cerebral hemorrhage or intra-cerebral aneurysm.
A patient for whom surgery that requires antiplatelet treatment intervention is scheduled within the next six months.

⑨ A patient with severe hepatic diseases (abdominal effusion) Platelet count at less than 80,000 cells/mm3 Hgb count at less than 10 g/dL

⑩ A patient who appears to be at risk of bradycardia (a patient with an insufficiency of the said function, or a patient without a permanent pacemaker despite a grade 2 or higher atrioventricular block).

⑪ A patient who tested positive in a pregnancy test, or is currently breastfeeding

⑫ A patient with less than one year of remaining life expectancy due to comorbidity (based on the medical judgment of the investigator).

⑬ A patient who is already participating in another randomized clinical study for other medicines or medical devices, where the primary end point has not been reached.

⑭ A patient who did not sign her informed consent form, or could not be traced in the long-term.