Turkish Chronic Total Occlusion Percutaneous Coronary Intervention Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAhmet Seyfeddin Gürbüz
About this trial
The TURK CTO Registry is a prospective, multicenter, observational registry designed to evaluate the contemporary management and outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in Türkiye.
The registry will include consecutive adult patients undergoing CTO PCI at participating centers. Detailed data on patient characteristics, cardiovascular risk factors, lesion and procedural characteristics, CTO crossing strategies, guidewires and devices, procedural techniques, radiation exposure, contrast use, procedural success, and in-hospital complications will be collected using a standardized electronic data collection system.
The primary objective of the registry is to characterize contemporary CTO PCI practice in Türkiye and to evaluate procedural success and safety. Secondary objectives include identifying clinical, angiographic, and procedural factors associated with technical and procedural success, complications, resource utilization, and patient outcomes.
The registry is expected to provide real-world, multicenter data on CTO PCI practice and to help identify factors associated with successful and safe CTO revascularization in Türkiye. No treatment or procedural strategy will be assigned by the study protocol; all clinical and procedural decisions will be made by the treating physicians according to routine clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Presence of at least one coronary chronic total occlusion (CTO), defined as a coronary artery lesion with TIMI grade 0 antegrade flow and an estimated duration of occlusion of ≥3 months
Undergoing an attempted PCI of the CTO at a participating center during the study period
Provision of informed consent when required by the applicable ethics committee and local regulations
Disqualifiers
Age <18 years
Coronary lesion not meeting the predefined criteria for CTO
No attempted CTO PCI during the procedure
Inability or refusal to provide informed consent when informed consent is required
Trial population
The study population will consist of consecutive adult patients undergoing attempted PCI for coronary chronic total occlusion (CTO) at participating centers in Türkiye. Both successful and unsuccessful procedures will be included. Repeat CTO PCI attempts and procedures involving different CTO lesions in the same patient will be eligible. Each procedural episode will be recorded separately and linked to the same patient using a unique study identifier, allowing patient-level and procedure-level analyses.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
70,000 Participants
are grouped into 1 trial groupGroup A: CTO PCI Cohort
Trial outcomes
Primary outcomes
1
Technical Success of CTO PCI
Technical success will be defined as successful CTO revascularization resulting in \<30% residual stenosis and restoration of TIMI grade 3 antegrade flow in the treated vessel at the completion of the CTO PCI procedure. The proportion of CTO PCI procedures achieving technical success will be assessed.
Time frame
At the end of the index CTO PCI procedure2
Procedural Success of CTO PCI
Procedural success will be defined as achievement of technical success without the occurrence of an in-hospital major adverse event. The proportion of CTO PCI procedures meeting the predefined criteria for procedural success will be assessed.
Time frame
From the CTO PCI procedure through hospital discharge, typically within 7 daysSecondary outcomes
1
In-Hospital Major Adverse Cardiovascular and Cerebrovascular Events
The incidence of in-hospital major adverse cardiovascular and cerebrovascular events will be assessed. Events will include all-cause death, myocardial infarction, stroke, emergency coronary artery bypass graft surgery, and urgent repeat percutaneous coronary intervention occurring during the index hospitalization.
Time frame
From the CTO PCI procedure through hospital discharge, typically within 7 days.2
CTO PCI-Related Procedural Complications
The incidence of procedural complications related to CTO PCI will be assessed. Complications will include coronary perforation, including severity according to the Ellis classification; collateral-channel perforation; pericardial effusion; cardiac tamponade; need for pericardiocentesis; donor-vessel dissection or thrombosis; occlusion of a side branch ≥2.5 mm; vascular access complications; major bleeding, including bleeding classified according to the Bleeding Academic Research Consortium (BARC) criteria; need for blood transfusion; contrast-associated acute kidney injury; hemodynamic instability; treatment-requiring arrhythmia; and stent thrombosis. Individual complications will also be analyzed separately.
Time frame
During the CTO PCI procedure through hospital discharge, typically within 7 days.3
Major Adverse Cardiovascular and Cerebrovascular Events During Follow-up
The incidence of major adverse cardiovascular and cerebrovascular events during follow-up will be assessed. Clinical events will include all-cause death, cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis, target lesion revascularization, target vessel revascularization, any repeat coronary revascularization by percutaneous coronary intervention or coronary artery bypass graft surgery, and cardiovascular hospitalization. Individual components and relevant composite clinical endpoints will be analyzed.
Time frame
30 days, 6 months, 12 months, 24 months, and 36 months after the CTO PCI procedure.4
CTO Target-Vessel Reocclusion
The incidence of documented reocclusion of a successfully treated CTO vessel will be assessed during follow-up when clinically indicated coronary angiography or other appropriate coronary imaging is available. Reocclusion will be evaluated in relation to baseline lesion characteristics, procedural strategy, technical result, stent characteristics, and subsequent clinical events.
Time frame
Up to 36 months after the CTO PCI procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ahmet Seyfeddin Gürbüz
Lead sponsor
Necmettin Erbakan University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: