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Chronic Total Occlusion Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02352818
Enrollment
600
Registered
2015-02-02
Start date
2015-01-26
Completion date
2025-01-31
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Total Coronary Occlusions

Brief summary

The aim of this CTO registry is to gather data including patient demographic date, cardiac risk factors, procedural technical data and procedural success/outcome rates. Furthermore, we aim to evaluate the safety and performance of various CTO specific guidewires, devices (such as the CrossBoss/Stingray dissection re-entry device) and other recognised and approved techniques (retrograde wire escalation, retrograde dissection re-entry techniques). The incidence of recognized complications (dissections, perforations, cardiac tamponade, vascular complications, radiation injury, acute kidney injury) will also evaluated. The investigator will assess clinical outcome at 1 year after successful CTO procedures.

Detailed description

This objectives of this single-center CTO registry are to: 1. Gather prospective clinical data on all consecutive patients undergoing complex difficult CTO PCI procedures including patient demographic date, cardiac risk factors, procedural technical data (contrast volume, radiation exposure, procedure time and procedural success/outcome rates. 2. Evaluate the safety and performance of various CTO dedicated guidewires, devices (such as the CrossBoss/Stingray anterior dissection re-entry device) and other recognised and approved techniques (retrograde wire escalation, retrograde dissection re-entry techniques). 3. Evaluate the incidence and severity of recognized complications such as coronary dissections, coronary perforations (+/- need for emergency pericardiocentesis), acute kidney injury, radiation injury, access site vascular complications. 4. Evaluate the medium-term outcome (recurrence of symptoms, major cardiovascular events (cardiac death, myocardial infarction, target lesion revascularization, target vessel revascularization) during a routine out-patient consultation (planned as part of normal standard care) at 1 year post successful CTO PCI. After this consultation, the patient may choose to have cardiology follow-up at the UZ Leuven or with his/her referring cardiologist.

Interventions

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All consecutive patients undergoing an elective attempt at percutaneous revascularization of a chronic total occlusion are eligible for inclusion in the CTO registry. A chronic total occlusion is defined as an occluded coronary artery with TIMI 0 flow that has been occluded for 3 months or more. By definition all patients will have been judged to be acceptable candidates for an attempt at revascularization before consenting to be part of the CTO registry.

Exclusion criteria

* There are no specific

Design outcomes

Primary

MeasureTime frame
Succes rate of procedure1 year

Countries

Belgium

Contacts

Primary ContactJohan Bennett, MD
johan.bennett@uzleuven.be003216341916
Backup ContactKarin Broos
003216342465

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026