Safety IssuesLSCBRNCT06284057
Lower Silesia Culotte Bifurcation Registry (LSCBR).
An observational study of Safety Issues and Efficacy, Self, run by Miedziowe Centrum Zdrowia SA at 2 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety Issues, Efficacy, Self
- What is being tested?
- Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Apr 2013to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Presence of significant changes in the coronary bifurcation requiring the implantation of two coronary stents using the Culotte or DK Culotte technique.
Who cannot join
- Patients who underwent PCI with coronary stents prior to the index procedure for the bifurcation lesion studied.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Department of Cardiology, Provincial Specialized Hospital in Legnica,
Legnica, Lower Silesian Voivodeship, 59-220
Mateusz Barycki, M.D, +48767211446, mateusz.barycki@gmail.com
Piotr Rola, M.D. Ph.D, +48767211446, piotr.rola@gmail.com
- Recruiting
Department of Cardiology, The Copper Health Centre (MCZ)
Lubin, Lower Silesian Voivodeship, 59-300
Adrian Włodarczak, Assoc Prof., +48768460300, wlodarczak.adrian@gmail.com
Szymon Włodarczak, MD, +4876 846 03 00, wlodarczak.szy@gmail.com
About this study
Official title: Double Kissing (DK) vs Culotte Culotte. Lower Silesia Culotte Bifurcation Registry (LSCBR).
The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis.
Read the detailed 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.
- Conditions
- Safety Issues, Efficacy, Self
- Being tested
- Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte
- Keywords
- Percutaneous coronary intervention (PCI), Bifurcation lesion, Culotte Technique, Double Kiss Culotte Technique, Acute Coronary Syndrome, Two-Stent Technique
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) CulotteProcedure or surgery
Patient with CAD and coexisting bifurcation lesion requiring two-stent approach treated with Culotte Technique or Double Kiss (DK) Culotte due to operator distraction.
| Study group | Role | What they receive |
|---|---|---|
| Culotte Group | Data regarding patient with performed PCI- bifurcation with subsequent implantation of two stents using the Culotte technique Receives: 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. Receives: Procedure: Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The secondary composed outcome was MACE: myocardial infarction (MI), cardiac death, MB-TLR or/and SB-TLR
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Apr 2013
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miedziowe Centrum Zdrowia SA
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
- Responsible party
- Principal investigator, Adrian Włodarczak, Miedziowe Centrum Zdrowia SA
- Investigators
- Adrian Włodarczak, Assoc. Prof., Principal investigator, Miedziowe Centrum Zdrowia SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284057
- Sponsor's protocol ID
- CopperHealthCentre3
- Acronym
- LSCBR
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Kissing (DK) vs Culotte Culotte. Lower Silesia Culotte Bifurcation Registry (LSCBR).
- ClinicalTrials.gov ID
- NCT06284057
- Acronym / sponsor ID
- LSCBR / CopperHealthCentre3
- Conditions
- Safety Issues, Efficacy, Self
- Keywords
- Percutaneous coronary intervention (PCI), Bifurcation lesion, Culotte Technique, Double Kiss Culotte Technique, Acute Coronary Syndrome, Two-Stent Technique
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Miedziowe Centrum Zdrowia SAUniversity, hospital or other
- Collaborators
- Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culotte Group | – | Procedure: Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) CulotteData regarding patient with performed PCI- bifurcation with subsequent implantation of two stents using the Culotte technique |
| Double Kiss (DK) Culotte Group | – | Procedure: Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) CulotteData 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Presence of significant changes in the coronary bifurcation requiring the implantation of two coronary stents using the Culotte or DK Culotte technique.
Key exclusion criteria (1 listed)
- Patients who underwent PCI with coronary stents prior to the index procedure for the bifurcation lesion studied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) CulottePatient with CAD and coexisting bifurcation lesion requiring two-stent approach treated with Culotte Technique or Double Kiss (DK) Culotte due to operator distraction. | Procedure or surgery | Culotte Group, Double Kiss (DK) Culotte Group |
Primary outcome
Target lesion failure (TLF)
Time frame: 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)
The primary endpoint was target lesion failure (TLF): the composite of cardiac death, target vessel myocardial infarction (TVMI), or clinically driven TLR.
1 secondary outcome
MACE
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adrian Włodarczak, Assoc. Prof. principal investigator
Miedziowe Centrum Zdrowia SA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues and Efficacy, Self, run by Miedziowe Centrum Zdrowia SA at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mateusz Barycki, MD (+48767211446, mateusz.barycki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (TLF) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.