Lower Silesia Culotte Bifurcation Registry (LSCBR).

NCT ID: NCT06284057

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-01

Study Completion Date

2028-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Safety Issues Efficacy, Self

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Culotte Group

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

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

Intervention Type 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.

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.

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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Adrian Włodarczak

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adrian Włodarczak, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Cardiology, Provincial Specialized Hospital in Legnica,

Legnica, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Department of Cardiology, The Copper Health Centre (MCZ)

Lubin, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Mateusz Barycki, MD

Role: CONTACT

+48767211446

Adrian Włodarczak, Assoc. Prof.

Role: CONTACT

+48768460300

Facility Contacts

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Mateusz Barycki, M.D

Role: primary

+48767211446

Piotr Rola, M.D. Ph.D

Role: backup

+48767211446

Adrian Włodarczak, Assoc Prof.

Role: primary

+48768460300

Szymon Włodarczak, MD

Role: backup

+4876 846 03 00

Other Identifiers

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CopperHealthCentre3

Identifier Type: -

Identifier Source: org_study_id

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