Lower Silesia Culotte Bifurcation Registry (LSCBR).

Regional Cardiology Center, The Copper Health Centre (MCZ),

Status: Enrolling

Conditions: Safety Issues; Efficacy, Self

Treatments: Procedure: Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte

Study type: Observational

Funder types: Other

Identifiers

NCT06284057

CopperHealthCentre3

Details and patient eligibility

About

The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis.

Full description

The study contains a retrospective analysis of subjects who have undergone PCI in two high-volume cooperative Cardiac Departments in the Lower Silesia Region (Poland) between April 2012 and January 2024. Data regarding all performed PCI from these periods were prescreened in terms of bifurcation lesion with subsequent implantation of two stents using the Culotte technique or the DK-Culotte technique. The indication for percutaneous coronary intervention (PCI) was based either on a judgment made by the Heart Team or on a particular clinical indication (ongoing ischemia, lack of will for the alternative treatment options, presence of significant angiographic CAD suitable for PCI due to ESC/ESH recommendation). The decision to perform the two-stent technique PCI was left to the operator's dissertation based on clinical and angiographical features. All patients were thoroughly informed about all therapeutic options and PCI-related risks before providing written informed consent for the procedure. There were no clinical or vessel-related exclusion criteria (lesion anatomy, length, tortuosity, severity). However, patients who had undergone PCI with coronary stents prior to the index procedure with respect to the bifurcation lesion studied were excluded from the study.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of significant changes in the coronary bifurcation requiring the implantation of two coronary stents using the Culotte or DK Culotte technique.

Exclusion criteria

• Patients who underwent PCI with coronary stents prior to the index procedure for the bifurcation lesion studied.

Trial design

400 participants in 2 patient groups

Culotte Group

Description:

Data regarding patient with performed PCI- bifurcation with subsequent implantation of two stents using the Culotte technique

Treatment:

Procedure: Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte

Double Kiss (DK) Culotte Group

Description:

Data regarding patient with performed PCI- bifurcation with subsequent implantation of two stents using the Double Kiss- Culotte technique. DK-Culotte technique is a variety of classical "Culotte techniques" in which one additional kissing balloon dilation is performed just after SB stenting, and prior to MB stent implantation.

Treatment:

Procedure: Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte