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

November 9, 2023 updated by: Saint Vincent's Hospital, Korea

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

[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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 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.
  2. 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 Type

Interventional

Enrollment (Estimated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16247
        • Recruiting
        • St. Vincent's Hospital , the Catholic University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
target lesion failure the number of events
Time Frame: 12 months after randomization
composite outcomes the number of events (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization)
12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Vincent's Hospital, Korea

Investigators

  • Principal Investigator: Sung-Ho Her, MD. PhD., St Vincent's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XC22EIDI0051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Procedure: planed 2-stent strategy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe