Simple Crossover Versus Side Branch Opening in Patients With Non-Left Main Bifurcation Lesion

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorKeimyung University Dongsan Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

(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

Disqualifiers

(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)

Trial design

Treatments tested in this trial

  • Simple Crossover
  • Side branch opening

Treatment groups

1,000 Participants
are divided into 2 treatment groups

Locations

This trial has no locations