Chronic Total Coronary OcclusionsNCT02352818
Chronic Total Occlusion Registry
An observational study of Chronic Total Coronary Occlusions, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Coronary Occlusions
- What is being tested?
- no study intervention
- How many people
- 600 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jan 2015to Jan 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All patients undergoing percutaneous attempt at revascularisation of a chronic total coronary occlusion
Who may be able to join
- 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.
Who cannot join
- There are no specific exclusion criteria. If the patient does not wish to consent to having his personal data kept in a registry the patient will not be included in the CTO registry.
Trial locations and contacts
1 site in 1 country.
Karin Broos contact
Belgium1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Disease, University Hospitals Leuven
Leuven, 3000
Karin Broos, 003216342465, Karin.broos@uzleuven.be
Johan Bennett, MD, PhD
About this study
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.
Read the detailed description
This objectives of this single-center CTO registry are to:
- 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.
- 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).
- 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.
- 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.
- Conditions
- Chronic Total Coronary Occlusions
- Being tested
- no study intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no study interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Succes rate of procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study start26 Jan 2015
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Coronary OcclusionsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352818
- Sponsor's protocol ID
- S57285
- Status last verified
- Jul 2024
- First submitted
- 28 Jan 2015
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Total Occlusion Registry
- ClinicalTrials.gov ID
- NCT02352818
- Acronym / sponsor ID
- S57285
- Conditions
- Chronic Total Coronary Occlusions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 26 Jan 2015
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- 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 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:
- 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.
- 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).
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing percutaneous attempt at revascularisation of a chronic total coronary occlusion
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria. If the patient does not wish to consent to having his personal data kept in a registry the patient will not be included in the CTO registry.
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 |
|---|---|---|
| no study intervention | Other | – |
Primary outcome
Succes rate of procedure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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. This study is not recruiting at the moment.
Karin Broos contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Total Coronary Occlusions, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Bennett, MD (003216341916, johan.bennett@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Succes rate of procedure (time frame: 1 year). 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 3 Jul 2024.