Coronary Total OcclusionLT-CTONCT06544174
Long-term Clinical Follow-up After PCI for CTO
An observational study of Coronary Total Occlusion, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The research aimed to evaluate the impact of a successful Percutaneous coronary intervention of chronic total occlusions (CTO-PCI) on long-term MACE (Major Cardiovascular Events), symptoms, survival, Left Ventricular Ejection Fraction (LVEF) and myocardial ischemia up-to-8-years follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Total Occlusion
- What is being tested?
- Percutaneous Coronary Intervention of CTO
- How many people
- 448 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 1 May 2024
- 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 who underwent an attempt of percutaneous recanalization of a CTO at Montpellier University Hospital between January 2015 and December 2022. All patients had symptoms (angina or dyspnea) and/or reversible myocardial ischemia in the territory of the occluded artery and myocardial viability
Who may be able to join
- 18 years or older
- who underwent at least one CTO procedure between 2025 and 2022 in Montpellier University Hospital
- symptomatic of reversible myocardial ischemia
- proof of myocardial viability
Who cannot join
- refusal of the patient to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
The research aimed to evaluate the impact of a successful Percutaneous coronary intervention of chronic total occlusions (CTO-PCI) on long-term MACE (Major Cardiovascular Events), symptoms, survival, Left Ventricular Ejection Fraction (LVEF) and myocardial ischemia up-to-8-years follow-up.
Read the detailed description
With this observational and prospective study, this research aimed to evaluate the impact of a successful CTO-PCI on long-term MACE (Major Cardiovascular Events), symptoms, survival, LVEF and myocardial ischemia up-to-8-years follow-up.
- Conditions
- Coronary Total Occlusion
- Being tested
- Percutaneous Coronary Intervention of CTO
- Keywords
- CTO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention of CTOOther
CTO-PCI is a procedure of interventional cardiology attempting revascularisation of the CTO
| Study group | Role | What they receive |
|---|---|---|
| Successful CTO-PCI | Success was defined as a procedure achieving a final residual stenosis < 30% (by visual estimation) and a TIMI flow grade 3 after CTO recanalization in all living patients within 24h following angioplasty. Receives: Other: Percutaneous Coronary Intervention of CTO | |
| Failed CTO-PCI | Success was defined as a procedure achieving a final residual stenosis < 30% (by visual estimation) and a TIMI flow grade 3 after CTO recanalization in all living patients within 24h following angioplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular events (MACE)
Incidence of composite of cardiac death, non-fatal myocardial infarction and new target vessel revascularization
Measured: Up to 8 years
Secondary outcomes (6)
Non combined MACE components
Incidence of Cardiac death, non-fatal myocardial infarction and new target vessel revascularization
Measured: Up to 8 years
In-hospital events
Incidence of Procedural complications including death, periprocedural MI, coronary perforation, pericardial tamponade requiring drainage, local vascular complications, major bleeding, contrast induced nephropathy, stroke
Measured: Up to one week
Restenosis
Incidence of Restenosis Defined as a greater than 50% diameter stenosis at follow-up angiogram of the first dilated total occlusion. Reocclusion was defined as recurrent total occlusion of the first dilated total occlusion.
Measured: Up to 8 years
Ischemic burden
Comparison between pre and post-CTO ischemic tests
Measured: Up to 8 years
Stent thrombosis
Incidence of stent thrombosis defined as any myocardial infarction with angiographic confirmation of in-stent thrombus or unexplained death
Measured: Within 30 days after the procedure
LVEF
Percentage of Increase or decrease in LVEF after the CTO procedure compared with baseline LVEF
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Total OcclusionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Leclercq, PU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544174
- Sponsor's protocol ID
- 2024-01-008 LECLERCQ
- Acronym
- LT-CTO
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinical Follow-up After PCI for CTO
- ClinicalTrials.gov ID
- NCT06544174
- Acronym / sponsor ID
- LT-CTO / 2024-01-008 LECLERCQ
- Conditions
- Coronary Total Occlusion
- Keywords
- CTO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 9 Aug 2024 (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 research aimed to evaluate the impact of a successful Percutaneous coronary intervention of chronic total occlusions (CTO-PCI) on long-term MACE (Major Cardiovascular Events), symptoms, survival, Left Ventricular Ejection Fraction (LVEF) and myocardial ischemia up-to-8-years follow-up.
Detailed description
With this observational and prospective study, this research aimed to evaluate the impact of a successful CTO-PCI on long-term MACE (Major Cardiovascular Events), symptoms, survival, LVEF and myocardial ischemia up-to-8-years follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful CTO-PCI | – | Other: Percutaneous Coronary Intervention of CTOSuccess was defined as a procedure achieving a final residual stenosis < 30% (by visual estimation) and a TIMI flow grade 3 after CTO recanalization in all living patients within 24h following angioplasty. |
| Failed CTO-PCI | – | –Success was defined as a procedure achieving a final residual stenosis < 30% (by visual estimation) and a TIMI flow grade 3 after CTO recanalization in all living patients within 24h following angioplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent an attempt of percutaneous recanalization of a CTO at Montpellier University Hospital between January 2015 and December 2022. All patients had symptoms (angina or dyspnea) and/or reversible myocardial ischemia in the territory of the occluded artery and myocardial viability
Key inclusion criteria (4 listed)
- 18 years or older
- who underwent at least one CTO procedure between 2025 and 2022 in Montpellier University Hospital
- symptomatic of reversible myocardial ischemia
- proof of myocardial viability
Key exclusion criteria (1 listed)
- refusal of the patient to participate to the study
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 |
|---|---|---|
| Percutaneous Coronary Intervention of CTOCTO-PCI is a procedure of interventional cardiology attempting revascularisation of the CTO | Other | Successful CTO-PCI |
Primary outcome
Major cardiovascular events (MACE)
Time frame: Up to 8 years
Incidence of composite of cardiac death, non-fatal myocardial infarction and new target vessel revascularization
6 secondary outcomes
Non combined MACE components
Time frame: Up to 8 years
In-hospital events
Time frame: Up to one week
Restenosis
Time frame: Up to 8 years
Ischemic burden
Time frame: Up to 8 years
Stent thrombosis
Time frame: Within 30 days after the procedure
LVEF
Time frame: Up to 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Coronary Total Occlusion
Not yet recruitingObservational study
Relationship Between Frontal QRS-T Angle and Collateral Circulation in Coronary Artery Chronic Total Occlusion
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Active, not recruiting
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
Chronic Total Occlusion of Coronary Artery
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Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
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Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE)
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TRIO CTO (Taiwan Research Initiative on Coronary Total Occlusion)
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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.
Florence Leclercq, PU-PH principal investigator
University Hospital, Montpellier
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 Coronary Total Occlusion, run by University Hospital, Montpellier at 1 site in France.
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 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: finished, as of the sponsor's last update on 19 Sep 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiovascular events (MACE) (time frame: Up to 8 years). 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 19 Sep 2024.