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

ConditionCoronary Artery Disease

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Simple Crossover
Procedure/Surgery
Regardless of allocated arms, stent implantation in the MV (selected 1:1 according to the distal MV size) followed by systematic proximal optimization technique (POT, post-dilatation of the stent at the level of proximal MV with a balloon diameter sized 1:1 according to the proximal MV) or POT like procedure is strongly recommended.
Side branch opening
Procedure/Surgery
According to the latest European Bifurcation Club (EBC) consensus document, distal SB rewiring followed by kissing balloon inflation (eventually conducted with short non-compliant balloons) and repeat POT procedures are highly recommended. An additional stent will be allowed if major dissection or decreased TIMI flow of SB occurs during SB treatment.

Treatment groups

1,000 Participants

are divided into 2 treatment groups

Group A: Simple crossover armExperimental treatment 1 intervention

Group B: Side branch opening armActive comparator 1 intervention

Trial outcomes