Lower Silesia Culotte Bifurcation Registry (LSCBR).

NCT06284057 | Recruiting

• 1 other identifier: CopperHealthCentre3
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Safety Issues; Efficacy, Self

Keywords

Percutaneous coronary intervention (PCI); Bifurcation lesion; Culotte Technique; Double Kiss Culotte Technique; Acute Coronary Syndrome; Two-Stent Technique

Outcome Measures

Primary Outcomes (1)

• Target lesion failure (TLF)

  The primary endpoint was target lesion failure (TLF): the composite of cardiac death, target vessel myocardial infarction (TVMI), or clinically driven TLR.

  Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)

Secondary Outcomes (1)

• MACE

  Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)

Other Outcomes (2)

• Stent thrombosis

  Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)

• Stent restenosis

  Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)

Study Arms (2)

Culotte Group

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

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

Double Kiss (DK) Culotte Group

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.

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

Interventions

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

Patient with CAD and coexisting bifurcation lesion requiring two-stent approach treated with Culotte Technique or Double Kiss (DK) Culotte due to operator distraction.

Culotte Group; Double Kiss (DK) Culotte Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes a retrospective analysis of subjects who underwent PCI in two cooperative cardiac centers in the Lower Silesia region between April 2012 and January 2024. Data from the participating centers on all PCIs performed during these periods were prescreened for bifurcation lesions with subsequent implantation of two stents using the Culotte technique or the DK-Culotte technique. The indication for percutaneous coronary intervention (PCI) was based on the judgment of the cardiac team or on a specific clinical indication (persistent ischemia, unwillingness to accept alternative treatment options, presence of significant angiographic CAD suitable for PCI). The decision to perform PCI with the two-stent technique was left to the operator's judgment based on clinical and angiographic characteristics.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Regional Cardiology Center, The Copper Health Centre (MCZ),: lead
• Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.: collaborator

Study Sites (2)

Department of Cardiology, Provincial Specialized Hospital in Legnica,

Legnica, Lower Silesian Voivodeship, 59-220, Poland

RECRUITING

Department of Cardiology, The Copper Health Centre (MCZ)

Lubin, Lower Silesian Voivodeship, 59-300, Poland

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Adrian Włodarczak, Assoc. Prof.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mateusz Barycki, MD

CONTACT

+48767211446; mateusz.barycki@gmail.com

Adrian Włodarczak, Assoc. Prof.

CONTACT

+48768460300; adrian.wlodarczak@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: April 1, 2013
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

PL (2)