Coronary Artery Disease (CAD)AGECTONCT07442526
AGECTO Study: PCI vs. Optimal Medical Therapy for CTO in the Octogenarian Patients
An observational study of Coronary Artery Disease (CAD) and Chronic Total Occlusion (CTO), run by San Luigi Gonzaga Hospital at 1 site in Italy.
Trial summary
The study compares an interventional strategy (PCI) with optimal medical therapy (OMT) in ultra-octogenarians with chronic total occlusions (CTO). Results suggest that successful PCI leads to significant improvements in symptoms and quality of life compared to OMT alone. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease (CAD), Chronic Total Occlusion (CTO), Percutaneous Coronary Intervention (PCI)
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Octogenarian patients (age ≥80 years) with a documented CTO will be potential enrolled.
Who may be able to join
- Age ≥ 80 years.
- CTO in at least one major coronary artery.
- Complete revascularization or non-critical stenosis in the non-CTO vessels.
- Life expectancy > 1-year
Who cannot join
- Severe non-cardiac comorbidities with a life expectancy < 1 year.
- CTOs in the native vessel and patency grafts in CABG patients
- CTOs in the minor vessel (Non dominant RCA, small diagonal or obtuse marginal branch)
- Lack of any anatomical or clinical details of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AGECTO Study: A Comparative Study of Percutaneous Coronary Intervention vs. Medical Therapy for Chronic Total Occlusion in Octogenarian Patients
The study compares an interventional strategy (PCI) with optimal medical therapy (OMT) in ultra-octogenarians with chronic total occlusions (CTO).
Results suggest that successful PCI leads to significant improvements in symptoms and quality of life compared to OMT alone. While initially carrying higher procedural risks, CTO-PCI is considered feasible and safe in experienced centers. There is also potential for long-term benefits in survival and a reduction in major adverse cardiovascular events (MACE). The choice between treatments depends on an individual risk-benefit assessment, considering the patient's overall condition.
Read the detailed description
Coronary artery disease (CAD) in the elderly is a growing healthcare concern, with chronic total occlusion (CTO) representing a particularly challenging and complex subset. Despite the increasing prevalence of CTO in older patients, there remains significant controversy and a lack of specific evidence regarding the optimal management strategy for this population.
Recent advancements in CTO percutaneous coronary intervention (PCI) techniques have improved success rates and reduced procedural risks. However, older patients (particularly those aged 80 and above) are often underrepresented or excluded from major clinical trials due to perceived higher risks, comorbidities, and potentially reduced life expectancy. This has led to a significant evidence gap regarding the specific benefits and risks of CTO PCI in the very elderly.
Consequently, many octogenarian patients with CTO are primarily managed with optimal medical therapy (OMT), not based on robust clinical trial data but often due to physician and institutional bias, age-based exclusion criteria, and a reluctance to pursue invasive procedures in this age group. This often results in a "treatment disparity," where patients are denied access to potentially beneficial interventions based solely on their chronological age, rather than their functional status or individual risk profile.
The rationale for the AGECTO study is to address this crucial clinical and ethical gap. By comparing the outcomes of CTO PCI with OMT in a dedicated cohort of octogenarian patients, this study aims to provide initial evidence-based data to guide clinical decision-making. We hypothesize that CTO PCI, when performed successfully in this carefully selected population, offers significant benefits in terms of symptom relief and potentially long-term clinical outcomes compared to OMT alone.
- Conditions
- Coronary Artery Disease (CAD), Chronic Total Occlusion (CTO), Percutaneous Coronary Intervention (PCI), Optimal Medical Therapy
- Keywords
- Chronic Total Occlusion (CTO), Percutaneous Coronary Intervention (PCI), Optimal Medical Therapy (OMT), Octogenarians
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Octogenarians with Chronic Total Occlusion in at least one major coronary vessel | Older patients >80 years with chronic coronary syndrome and CTOs with a life expectancy > 1-year undergoing to CTO PCI or OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (Major Cardiovascular Events)
MACE is defined as a composite of all-cause mortality, non-fatal myocardial infarction, and repeat revascularization.
Measured: From enrollment to 1-year
Secondary outcomes (1)
Quality of life (recurrent angina, dyspnea, re-hospitalization for cardiac causes)
Quality of life will be assess in the long-term impact of treatment strategy on symptoms, functional capacity and re-hospitalization for cardiac causes.
Measured: From the enrollment to 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 Mar 2026
- Study start1 Jul 2025
- Primary completion1 Sep 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Cerrato, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442526
- Sponsor's protocol ID
- Rivoli Hospital - aslTO3
- Other IDs
- AGECTO
- Acronym
- AGECTO
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Non necessary
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGECTO Study: A Comparative Study of Percutaneous Coronary Intervention vs. Medical Therapy for Chronic Total Occlusion in Octogenarian Patients
- ClinicalTrials.gov ID
- NCT07442526
- Acronym / sponsor ID
- AGECTO / Rivoli Hospital - aslTO3
- Conditions
- Coronary Artery Disease (CAD), Chronic Total Occlusion (CTO), Percutaneous Coronary Intervention (PCI), Optimal Medical Therapy
- Keywords
- Chronic Total Occlusion (CTO), Percutaneous Coronary Intervention (PCI), Optimal Medical Therapy (OMT), Octogenarians
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Mar 2026 (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 study compares an interventional strategy (PCI) with optimal medical therapy (OMT) in ultra-octogenarians with chronic total occlusions (CTO).
Results suggest that successful PCI leads to significant improvements in symptoms and quality of life compared to OMT alone. While initially carrying higher procedural risks, CTO-PCI is considered feasible and safe in experienced centers. There is also potential for long-term benefits in survival and a reduction in major adverse cardiovascular events (MACE). The choice between treatments depends on an individual risk-benefit assessment, considering the patient's overall condition.
Detailed description
Coronary artery disease (CAD) in the elderly is a growing healthcare concern, with chronic total occlusion (CTO) representing a particularly challenging and complex subset. Despite the increasing prevalence of CTO in older patients, there remains significant controversy and a lack of specific evidence regarding the optimal management strategy for this population.
Recent advancements in CTO percutaneous coronary intervention (PCI) techniques have improved success rates and reduced procedural risks. However, older patients (particularly those aged 80 and above) are often underrepresented or excluded from major clinical trials due to perceived higher risks, comorbidities, and potentially reduced life expectancy. This has led to a significant evidence gap regarding the specific benefits and risks of CTO PCI in the very elderly.
Consequently, many octogenarian patients with CTO are primarily managed with optimal medical therapy (OMT), not based on robust clinical trial data but often due to physician and institutional bias, age-based exclusion criteria, and a reluctance to pursue invasive procedures in this age group. This often results in a "treatment disparity," where patients are denied access to potentially beneficial interventions based solely on their chronological age, rather than their functional status or individual risk profile.
The rationale for the AGECTO study is to address this crucial clinical and ethical gap. By comparing the outcomes of CTO PCI with OMT in a dedicated cohort of octogenarian patients, this study aims to provide initial evidence-based data to guide clinical decision-making. We hypothesize that CTO PCI, when performed successfully in this carefully selected population, offers significant benefits in terms of symptom relief and potentially long-term clinical outcomes compared to OMT alone.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Octogenarians with Chronic Total Occlusion in at least one major coronary vessel | – | –Older patients >80 years with chronic coronary syndrome and CTOs with a life expectancy > 1-year undergoing to CTO PCI or OMT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Octogenarian patients (age ≥80 years) with a documented CTO will be potential enrolled.
Key inclusion criteria (4 listed)
- Age ≥ 80 years.
- CTO in at least one major coronary artery.
- Complete revascularization or non-critical stenosis in the non-CTO vessels.
- Life expectancy > 1-year
Key exclusion criteria (4 listed)
- Severe non-cardiac comorbidities with a life expectancy < 1 year.
- CTOs in the native vessel and patency grafts in CABG patients
- CTOs in the minor vessel (Non dominant RCA, small diagonal or obtuse marginal branch)
- Lack of any anatomical or clinical details of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE (Major Cardiovascular Events)
Time frame: From enrollment to 1-year
MACE is defined as a composite of all-cause mortality, non-fatal myocardial infarction, and repeat revascularization.
1 secondary outcome
Quality of life (recurrent angina, dyspnea, re-hospitalization for cardiac causes)
Time frame: From the enrollment to 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Non necessary
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Artery Disease (CAD) and Chronic Total Occlusion (CTO), run by San Luigi Gonzaga Hospital at 1 site in Italy.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
MACE (Major Cardiovascular Events) (time frame: From enrollment to 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 2 Mar 2026.