Coronary Artery DiseaseADRENALINENCT06878729
Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI
A study testing CTO PCI using ADR strategy and CTO PCI using retrograde strategy in people with Coronary Artery Disease and Coronary Occlusion, run by National Institute of Cardiology, Warsaw, Poland at 3 sites in Poland.
Trial summary
The ADRENALINE trial has been designed as a multi-center, prospective randomized study to compare the procedural and periprocedural outcomes of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using antegrade dissection and re-entry (ADR) versus retrograde strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention
- What is being tested?
- CTO PCI using ADR strategy and CTO PCI using retrograde strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesPoland
- Study dates
- 28 Jul 2025to 30 Sep 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability)
- at least difficult native CTO lesion with J-CTO difficulty score ≥2 points on invasive angiography
- angiographic suitability for both ADR and the retrograde strategy as assessed by 2 independent hybrid CTO PCI operators
- informed consent for participation in the study
Who cannot join
- <18 years of age
- acute myocardial infarction
- cardiogenic shock
- severe valvular disease
- estimated life expectancy <1 year
- contraindication to PCI
Show all 10Show fewer
- contrast allergy
- positive pregnancy test or breast-feeding
- native CTO lesion with easy or intermediate difficulty score on invasive angiography (J-CTO score <2 points)
- lack of angiographic equipoise between the ADR and the retrograde strategy as assessed by 2 independent hybrid CTO PCI operators
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland3 sites, 3 recruiting
- Recruiting
1st Military Clinical Hospital
Lublin
Grzegorz Sobieszek, 004881261183666
- Recruiting
Hospital of the Ministry of the Interior and Administration
Lublin
Jakub Drozd, 0048817284626, sekretariat@szpitalmsw.pl
- Recruiting
National Institute of Cardiology
Warsaw, Warsaw
Maksymilian Opolski
About this study
Official title: Antegrade Dissection and Re-entry Versus Retrograde Strategy in Chronic Total Occlusion Percutaneous Coronary Intervention
The ADRENALINE trial has been designed as a multi-center, prospective randomized study to compare the procedural and periprocedural outcomes of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using antegrade dissection and re-entry (ADR) versus retrograde strategy. Beyond the patient-oriented outcomes, the influence of the studied CTO PCI strategies on the stress levels among interventional cardiologists will be explored.
The main questions it aims to answer are as follows:
Read more
- What is the difference between ADR versus retrograde strategy with regard to total procedure time, the rates of successful guidewire crossing and periprocedural complications as well as stress levels experienced by interventional cardiologists?
- Is retrograde approach associated with higher rates of myocardial injury/infarction based on cardiac troponin/cardiac magnetic resonance (CMR) as compared with ADR?
Participants will undergo pre- and postprocedural laboratory testing (cardiac troponin, CK-MB), CMR for late gadolinium enhancement and health status assessment. Subjects undergoing successful CTO PCI using antegrade wiring strategy will be included in the observational arm.
Read the detailed description
The ADRENALINE trial is planned as a multicenter, prospective randomized research experiment in patients with clinical indication for PCI of CTO. The target population will comprise patients with at least difficult CTO (J-CTO score ≥2) and angiographic equipoise for either ADR or the retrograde CTO recanalization strategy as evaluated by 2 independent CTO PCI operators. The pre-procedural assessment will comprise cardiac magnetic resonance (CMR) for late gadolinium enhancement, laboratory testing (cardiac troponin, creatine kinase-MB) and health status assessed by the Seattle angina questionnaire (SAQ) and the Rose Dyspnea Scale. Subsequently patients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or the retrograde CTO crossing strategy (n=74), while subjects undergoing successful antegrade wiring will be included in the observational arm (n=47). After CTO PCI, the cardiac troponin and creatine kinase-MB will be measured at 12 hours intervals (at least up to 24 hours), while CMR with late gadolinium enhancement will be repeated within 5 days post-procedure (including the observational arm). The health status of the study participants (SAQ and the Rose Dyspnea Scale) will be re-assessed at 3-months post-CTO PCI. In addition, to investigate the effect of the studied CTO PCI strategies on the occupational hazard of interventional cardiologists, the physical and mental stress levels experienced by CTO operators will be continuously monitored during the procedure. The co-primary endpoint is defined as: 1) total procedure time and 2) successful guidewire crossing through CTO. The secondary endpoints include: time of successful guidewire crossing through CTO, final technical success of CTO PCI, radiation dose, contrast volume, equipment cost, procedural complications, rate of periprocedural myocardial injury, rate of new myocardial infarction on CMR, quality of life, target lesion failure (cardiac death, target vessel-related myocardial infarction, and clinically-driven target lesion revascularization) at 3 months follow-up, and stress indices experienced by physicians during the procedure.
- Being tested
- CTO PCI using ADR strategy, CTO PCI using retrograde strategy
- Keywords
- coronary artery disease, percutaneous coronary intervention, coronary chronic total occlusion, antegrade dissection and re-entry, retrograde strategy
- Medical subject headings
- Coronary Artery Disease, Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO PCI using ADR strategyProcedure or surgery
CTO recanalization using ADR performed as primary or secondary CTO PCI strategy (i.e. in case of unattempted or failed antegrade wiring, respectively).
CTO PCI using retrograde strategyProcedure or surgery
CTO recanalization using retrograde approach performed as primary or secondary CTO PCI strategy (i.e. in case of unattempted or failed antegrade wiring, respectively).
| Study group | Role | What they receive |
|---|---|---|
| ADR strategy | Other | Patients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or retrograde CTO crossing strategy. The ADR, as part of the antegrade approach, involves extraplaque crossing of the occluded coronary artery with subsequent reentry into the distal true lumen using dedicated reentry systems or knuckle wire techniques. Receives: Procedure: CTO PCI using ADR strategy |
| Retrograde strategy | Other | Patients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or retrograde CTO crossing strategy. The retrograde technique, planned as the comparator to the ADR strategy, relies on crossing the occluded coronary artery from the distal vessel (i.e. against the original direction of blood flow). Retrograde CTO crossing is attempted either with retrograde intraplaque wiring or more frequently using the retrograde dissection and reentry techniques. Receives: Procedure: CTO PCI using retrograde strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total procedure time
Total procedure time in minutes.
Measured: procedural (1 day)
Successful guidewire crossing through CTO
Rate of successful guidewire crossing through CTO.
Measured: procedural (1 day)
Secondary outcomes (27)
Technical success
Achievement of Thrombolysis In Myocardial Infarction grade 3 flow in all ≥2.5-mm distal branches with <30% residual stenosis.
Measured: procedural (1 day)
Time of successful guidewire crossing
Time of successful guidewire crossing through CTO in minutes defined as the time from starting ADR or the retrograde approach to the time of successful CTO recanalization using any technique.
Measured: procedural (1 day)
Fluoroscopy time
Fluoroscopy time in minutes.
Measured: procedural (1 day)
Radiation dose
Total radiation dose in Gy and mGycm2.
Measured: procedural (1 day)
Contrast volume
Total contrast volume in mL.
Measured: procedural (1 day)
Cost of CTO PCI
Total cost of CTO PCI procedure in PLN.
Measured: procedural (1 day)
Number and type of procedural complications
Total number and specification of procedural complications (death, non-fatal myocardial infarction, cardiac tamponade requiring pericardiocentesis, coronary perforation, stroke, major bleeding according to Bleeding Academic Research Consortium).
Measured: procedural (1 day)
Periprocedural myocardial injury
Any periprocedural myocardial injury based on the dynamics of cardiac troponin.
Measured: in-hospital (2-5 days)
Periprocedural myocardial infarction
Any periprocedural myocardial infarction based on the dynamics of creatine kinase-MB/cardiac troponin and according to Fourth universal definition of myocardial infarction.
Measured: in-hospital (2-5 days)
Myocardial infarction on CMR
Any new myocardial infarction as assessed on serial CMR with late gadolinium enhancement.
Measured: in-hospital (2-5 days)
Target lesion failure
Total number of cardiac death, target vessel-related myocardial infarction or clinically-driven target lesion revascularization.
Measured: 3-months
All-cause death
Any death observed.
Measured: 3-months
Cardiac death
Any cardiac death observed.
Measured: 3-months
Target vessel-related myocardial infarction
Any target vessel-related myocardial infarction observed.
Measured: 3-months
Clinically-driven target lesion revascularization
Any clinically-driven target lesion revascularization observed.
Measured: 3-months
CCS class
Quality of life assessed by the Canadian Cardiovascular Society (CCS) grading scale measuring the severity of exertional angina (it uses a scale from 1 to 4 where 1 means angina only occurs with strenuous, rapid or prolonged exertion, and 4 means angina is present at rest).
Measured: 3-months
SAQ score
Quality of life assessed by the Seattle Angina Questionnaire comprising a 19-item questionnaire categorized into five scales (angina frequency, angina stability, physical limitations, treatment satisfaction, and disease-specific quality of life) with each scale transformed to a 0-100 score (the higher the score, the better the quality of life).
Measured: 3-months
Dyspnea severity on the Rose Dyspnea Scale
Quality of life assessed by the Rose dyspnea scale questionnaire measuring dyspnea complaints or shortness of breath (it consists of a score from 0 to 4, where 0 means no dyspnea complaints and 4 means the patient has complaints during no or minimal physical effort).
Measured: 3-months
Heart rate
Mean heart rate of the first CTO operator throughout CTO PCI.
Measured: operator-related (1 day)
Mean arterial pressure
Mean arterial pressure in mmHg of the first CTO operator throughout CTO PCI.
Measured: operator-related (1 day)
Systolic blood pressure
Mean systolic blood pressure in mmHg of the first CTO operator throughout CTO PCI.
Measured: operator-related (1 day)
Diastolic blood pressure
Mean diastolic blood pressure in mmHg of the first CTO operator throughout CTO PCI.
Measured: operator-related (1 day)
Blood glucose concentration
Continuous blood glucose concentration monitoring in mmol/l of the first CTO operator throughout CTO PCI.
Measured: operator-related (1 day)
Brain activity monitoring
Continuous brain activity monitoring via quantitative near infrared spectroscopy system assessing changes in relative concentrations of oxygenated and deoxygenated hemoglobin of the frontal cortex of the first CTO operator throughout CTO PCI.
Measured: operator-related (1 day)
Salivary cortisol concentration
Salivary cortisol concentration in ng/mL of the first CTO operator measured at 30-min intervals throughout CTO PCI.
Measured: operator-related (1 day)
High-sensitivity cardiac troponin concentration
Changes in the blood concentration of the high-sensitivity cardiac troponin (ng/L) pre- and post-CTO PCI in the first CTO operator.
Measured: operator-related (1 day)
Perceived Stress Scale score
Stress level assessment in the first CTO operator adapted to CTO procedure and based on the Perceived Stress Scale score containing 10 questions with a 5-point answer scale ranging from 0 ('never') to 4 ('very often') - the minimum score is 0 (indicating no stress) and the maximum score is 40 (indicating the highest level of stress).
Measured: operator-related (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start28 Jul 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either ADR or retrograde CTO crossing strategy in a 1:1 fashion.
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
- Investigators
- Maksymilian Opolski, Principal investigator, National Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878729
- Sponsor's protocol ID
- 2024/ABM/01/00006
- Other IDs
- 2024/ABM/01/00006
- Acronym
- ADRENALINE
- Status last verified
- Dec 2025
- First submitted
- 4 Mar 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Opolski MP, Spiewak M, Machaj F, Borzuta H, Sobieszek G, Drozd J, Kiljanski F, Matsko P, Klopotowski M, Zieba B, Kula W, Marczak M, Debski A, Witkowski A, Knaapen P, Leibundgut G, Ungureanu C, Rinfret S, Brilakis ES. Antegrade dissection and re-entry vs retrograde strategy in chronic total occlusion percutaneous coronary intervention: Rationale and design of the ADRENALINE randomized study. Am Heart J. 2026 Jul 11;301:107538. doi: 10.1016/j.ahj.2026.107538. Online ahead of print.
PubMed 42436000
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antegrade Dissection and Re-entry Versus Retrograde Strategy in Chronic Total Occlusion Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06878729
- Acronym / sponsor ID
- ADRENALINE / 2024/ABM/01/00006
- Keywords
- coronary artery disease, percutaneous coronary intervention, coronary chronic total occlusion, antegrade dissection and re-entry, retrograde strategy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 17 Mar 2025 (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 ADRENALINE trial has been designed as a multi-center, prospective randomized study to compare the procedural and periprocedural outcomes of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using antegrade dissection and re-entry (ADR) versus retrograde strategy. Beyond the patient-oriented outcomes, the influence of the studied CTO PCI strategies on the stress levels among interventional cardiologists will be explored.
The main questions it aims to answer are as follows:
- What is the difference between ADR versus retrograde strategy with regard to total procedure time, the rates of successful guidewire crossing and periprocedural complications as well as stress levels experienced by interventional cardiologists?
- Is retrograde approach associated with higher rates of myocardial injury/infarction based on cardiac troponin/cardiac magnetic resonance (CMR) as compared with ADR?
Participants will undergo pre- and postprocedural laboratory testing (cardiac troponin, CK-MB), CMR for late gadolinium enhancement and health status assessment. Subjects undergoing successful CTO PCI using antegrade wiring strategy will be included in the observational arm.
Detailed description
The ADRENALINE trial is planned as a multicenter, prospective randomized research experiment in patients with clinical indication for PCI of CTO. The target population will comprise patients with at least difficult CTO (J-CTO score ≥2) and angiographic equipoise for either ADR or the retrograde CTO recanalization strategy as evaluated by 2 independent CTO PCI operators. The pre-procedural assessment will comprise cardiac magnetic resonance (CMR) for late gadolinium enhancement, laboratory testing (cardiac troponin, creatine kinase-MB) and health status assessed by the Seattle angina questionnaire (SAQ) and the Rose Dyspnea Scale. Subsequently patients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or the retrograde CTO crossing strategy (n=74), while subjects undergoing successful antegrade wiring will be included in the observational arm (n=47). After CTO PCI, the cardiac troponin and creatine kinase-MB will be measured at 12 hours intervals (at least up to 24 hours), while CMR with late gadolinium enhancement will be repeated within 5 days post-procedure (including the observational arm). The health status of the study participants (SAQ and the Rose Dyspnea Scale) will be re-assessed at 3-months post-CTO PCI. In addition, to investigate the effect of the studied CTO PCI strategies on the occupational hazard of interventional cardiologists, the physical and mental stress levels experienced by CTO operators will be continuously monitored during the procedure. The co-primary endpoint is defined as: 1) total procedure time and 2) successful guidewire crossing through CTO. The secondary endpoints include: time of successful guidewire crossing through CTO, final technical success of CTO PCI, radiation dose, contrast volume, equipment cost, procedural complications, rate of periprocedural myocardial injury, rate of new myocardial infarction on CMR, quality of life, target lesion failure (cardiac death, target vessel-related myocardial infarction, and clinically-driven target lesion revascularization) at 3 months follow-up, and stress indices experienced by physicians during the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to either ADR or retrograde CTO crossing strategy in a 1:1 fashion.
| Arm | Type | Receives |
|---|---|---|
| ADR strategy | Other | Procedure: CTO PCI using ADR strategyPatients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or retrograde CTO crossing strategy. The ADR, as part of the antegrade approach, involves extraplaque crossing of the occluded coronary artery with subsequent reentry into the distal true lumen using dedicated reentry systems or knuckle wire techniques. |
| Retrograde strategy | Other | Procedure: CTO PCI using retrograde strategyPatients with either failed or unattempted primary antegrade wiring strategy will be evenly randomized (1:1 fashion) to either ADR or retrograde CTO crossing strategy. The retrograde technique, planned as the comparator to the ADR strategy, relies on crossing the occluded coronary artery from the distal vessel (i.e. against the original direction of blood flow). Retrograde CTO crossing is attempted either with retrograde intraplaque wiring or more frequently using the retrograde dissection and reentry techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability)
- at least difficult native CTO lesion with J-CTO difficulty score ≥2 points on invasive angiography
- angiographic suitability for both ADR and the retrograde strategy as assessed by 2 independent hybrid CTO PCI operators
- informed consent for participation in the study
Key exclusion criteria (10 listed)
- <18 years of age
- acute myocardial infarction
- cardiogenic shock
- severe valvular disease
- estimated life expectancy <1 year
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 |
|---|---|---|
| CTO PCI using ADR strategyCTO recanalization using ADR performed as primary or secondary CTO PCI strategy (i.e. in case of unattempted or failed antegrade wiring, respectively). | Procedure or surgery | ADR strategy |
| CTO PCI using retrograde strategyCTO recanalization using retrograde approach performed as primary or secondary CTO PCI strategy (i.e. in case of unattempted or failed antegrade wiring, respectively). | Procedure or surgery | Retrograde strategy |
Primary outcome
Total procedure time
Time frame: procedural (1 day)
Total procedure time in minutes.
Successful guidewire crossing through CTO
Time frame: procedural (1 day)
Rate of successful guidewire crossing through CTO.
27 secondary outcomes
Technical success
Time frame: procedural (1 day)
Time of successful guidewire crossing
Time frame: procedural (1 day)
Fluoroscopy time
Time frame: procedural (1 day)
Radiation dose
Time frame: procedural (1 day)
Contrast volume
Time frame: procedural (1 day)
Cost of CTO PCI
Time frame: procedural (1 day)
Number and type of procedural complications
Time frame: procedural (1 day)
Periprocedural myocardial injury
Time frame: in-hospital (2-5 days)
Periprocedural myocardial infarction
Time frame: in-hospital (2-5 days)
Myocardial infarction on CMR
Time frame: in-hospital (2-5 days)
Target lesion failure
Time frame: 3-months
All-cause death
Time frame: 3-months
Cardiac death
Time frame: 3-months
Target vessel-related myocardial infarction
Time frame: 3-months
Clinically-driven target lesion revascularization
Time frame: 3-months
CCS class
Time frame: 3-months
SAQ score
Time frame: 3-months
Dyspnea severity on the Rose Dyspnea Scale
Time frame: 3-months
Heart rate
Time frame: operator-related (1 day)
Mean arterial pressure
Time frame: operator-related (1 day)
Systolic blood pressure
Time frame: operator-related (1 day)
Diastolic blood pressure
Time frame: operator-related (1 day)
Blood glucose concentration
Time frame: operator-related (1 day)
Brain activity monitoring
Time frame: operator-related (1 day)
Salivary cortisol concentration
Time frame: operator-related (1 day)
High-sensitivity cardiac troponin concentration
Time frame: operator-related (1 day)
Perceived Stress Scale score
Time frame: operator-related (1 day)
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 2 Jan 2026.
- Derived from this study: PubMed 42436000Opolski MP, Spiewak M, Machaj F, Borzuta H, Sobieszek G, Drozd J, Kiljanski F, Matsko P, Klopotowski M, Zieba B, Kula W, Marczak M, Debski A, Witkowski A, Knaapen P, Leibundgut G, Ungureanu C, Rinfret S, Brilakis ES. Antegrade dissection and re-entry vs retrograde strategy in chronic total occlusion percutaneous coronary intervention: Rationale and design of the ADRENALINE randomized study. Am Heart J. 2026 Jul 11;301:107538. doi: 10.1016/j.ahj.2026.107538. Online ahead of print.
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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.
Maksymilian Opolski principal investigator
National Institute of Cardiology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTO PCI using ADR strategy and CTO PCI using retrograde strategy in people with Coronary Artery Disease and Coronary Occlusion, run by National Institute of Cardiology, Warsaw, Poland at 3 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 4 inclusion and 10 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 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Katarzyna Istynowicz (0048223434268, kistynowicz@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total procedure time (time frame: procedural (1 day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06878729, which also lists 1 linked publication.
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 2 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.