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

Primary Purpose

Coronary Artery Disease, Ischemic Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Procedure: planed 2-stent strategy
Procedure: provisional 1-stent plus DEB strategy
Sponsored by
Saint Vincent's Hospital, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, percutaneous coronary intervention, coronary bifurcation lesion, strategy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • St. Vincent's Hospital , the Catholic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional arm

PROVISION-DEB arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

target lesion failure the number of events
composite outcomes the number of events (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization)

Secondary Outcome Measures

Full Information

First Posted
July 31, 2023
Last Updated
August 17, 2023
Sponsor
Saint Vincent's Hospital, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT06002932
Brief Title
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
Acronym
PROVISIONDEB
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Vincent's Hospital, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Ischemic Heart Disease
Keywords
coronary artery disease, percutaneous coronary intervention, coronary bifurcation lesion, strategy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PROVISION-DEB arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Procedure: planed 2-stent strategy
Intervention Description
Procedure: planed 2-stent strategy
Intervention Type
Procedure
Intervention Name(s)
Procedure: provisional 1-stent plus DEB strategy
Intervention Description
Procedure: provisional 1-stent plus DEB strategy
Primary Outcome Measure Information:
Title
target lesion failure the number of events
Description
composite outcomes the number of events (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization)
Time Frame
12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung-Ho Her, MD. PhD.
Phone
+82312598397
Email
hhhsungho@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kyusup Lee, MD. PhD.
Phone
+821090590389
Email
ajobi7121@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Ho Her, MD. PhD.
Organizational Affiliation
St Vincent's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Hospital , the Catholic University
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Ho Her, MD. PhD.
Phone
+82312598397
Email
hhhsungho@naver.com
First Name & Middle Initial & Last Name & Degree
Kyusup Lee, MD. PhD.
Phone
+821090590389
Email
ajobi7121@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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