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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSaint Vincent's Hospital, Korea

About this trial

\[The Purpose of the Clinical Study\] 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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%.)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Procedure: planed 2-stent strategy

    Procedure/Surgery

    Procedure: planed 2-stent strategy

  • Procedure: provisional 1-stent plus DEB strategy

    Procedure/Surgery

    Procedure: provisional 1-stent plus DEB strategy

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: Conventional armActive comparator 1 intervention
Group B: PROVISION-DEB armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
12 months after randomization

Secondary outcomes

Other outcomes

Sponsors and contacts

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