NCT07761624

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70,000

participants targeted

Target at P75+ for all trials

Timeline
121mo left

Started Jul 2026

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jul 2026Jul 2036

Study Start

First participant enrolled

July 24, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2036

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

10 years

First QC Date

August 2, 2026

Last Update Submit

August 9, 2026

Conditions

Keywords

chronic total occlusioncoronary artery diseasepercutaneous coronary interventionantegrade approachretrograde approachTurk-Cto Registry

Outcome Measures

Primary Outcomes (2)

  • 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.

    At the end of the index CTO PCI procedure

  • 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.

    From the CTO PCI procedure through hospital discharge, typically within 7 days

Secondary Outcomes (13)

  • In-Hospital Major Adverse Cardiovascular and Cerebrovascular Events

    From the CTO PCI procedure through hospital discharge, typically within 7 days.

  • CTO PCI-Related Procedural Complications

    During the CTO PCI procedure through hospital discharge, typically within 7 days.

  • Major Adverse Cardiovascular and Cerebrovascular Events During Follow-up

    30 days, 6 months, 12 months, 24 months, and 36 months after the CTO PCI procedure.

  • CTO Target-Vessel Reocclusion

    Up to 36 months after the CTO PCI procedure.

  • Change in Left Ventricular Ejection Fraction

    Baseline and up to 36 months after the CTO PCI procedure.

  • +8 more secondary outcomes

Study Arms (1)

CTO PCI Cohort

Adult patients (≥18 years) undergoing attempted percutaneous coronary intervention (PCI) for at least one coronary chronic total occlusion (CTO) at participating centers in Türkiye will be prospectively enrolled. The cohort will include both successful and unsuccessful CTO PCI procedures, as well as repeat CTO PCI attempts. If a patient undergoes more than one CTO PCI attempt or treatment of more than one CTO lesion during the study period, each eligible procedure will be recorded as a separate procedural episode and linked to the same patient using a unique study identifier. No specific CTO PCI strategy, technique, device, or treatment will be assigned by the study protocol. All procedural and clinical decisions will be made by the treating physicians according to routine clinical practice.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Withdrawal of consent from participation in the registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dicle University, Faculty of Medicine

Diyarbakır, Turkey (Türkiye)

Location

Siyami Ersek Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Acıbadem Kent Hospital

Izmir, Turkey (Türkiye)

Location

izmir katip celebi university, Ataturk Education and Research Hospital

Izmir, Turkey (Türkiye)

Location

Necmettin Erbakan University, Faculty of Medicine

Konya, 42020, Turkey (Türkiye)

Location

Inonu University, Faculty of Medicine

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ahmet S Gurbuz, Professor

    Necmettin Erbakan University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet S Gurbuz, PROFESSOR

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 12, 2026

Study Start

July 24, 2026

Primary Completion (Estimated)

July 24, 2036

Study Completion (Estimated)

July 24, 2036

Last Updated

August 12, 2026

Record last verified: 2026-08

Locations