Lower Silesia Culotte Bifurcation Registry (LSCBR).

Safety Issues Clinical Trial

— LSCBR  

Official title:

Double Kissing (DK) vs Culotte Culotte. Lower Silesia Culotte Bifurcation Registry (LSCBR).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284057
• Other study ID #: CopperHealthCentre3
• Status: Recruiting
• Start date: April 1, 2013
• Est. completion date: April 1, 2028

Study information

• Verified date: March 2024
• Source: Regional Cardiology Center, The Copper Health Centre (MCZ),
• Contact: Mateusz Barycki, MD
• Phone: +48767211446
• Email: mateusz.barycki[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy, Self
• Safety Issues

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Cardiology, Provincial Specialized Hospital in Legnica,	Legnica	Lower Silesia
Poland	Department of Cardiology, The Copper Health Centre (MCZ)	Lubin	Lower Silesia

Sponsors (2)

Lead Sponsor	Collaborator
Regional Cardiology Center, The Copper Health Centre (MCZ),	Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stent thrombosis	Stent thrombosis in a stent implanted in a bifurcation during primary intervention. Stent thrombosis was defined according to The Academic Research Consortium-2 consensus document.; The presence of a thrombus† that originates in the stent/scaffold or in the segment 5 mm proximal or distal to the stent/scaffold or in a side branch originating from the stented/scaffolded segment and the presence of at least 1 of the following criteria: 1)Acute onset of ischemic symptoms at rest 2)New electrocardiographic changes suggestive of acute ischemia 3)Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous myocardial infarction) or Pathological confirmation of stent/scaffold 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)
Other	Stent restenosis	Stent restenosis in a stent placed in a bifurcation during primary intervention. Stent restenosis should be confirmed by either angiography or intravascular assessment.	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)
Primary	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	MACE	The secondary composed outcome was MACE: myocardial infarction (MI), cardiac death, MB-TLR or/and SB-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)