AGECTO Study: PCI vs. Optimal Medical Therapy for CTO in the Octogenarian Patients (AGECTO)

February 24, 2026 updated by: Enrico Cerrato, San Luigi Gonzaga Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rivoli, Italy, 10098
        • Rivoli Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Octogenarian patients (age ≥80 years) with a documented CTO will be potential enrolled.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (recurrent angina, dyspnea, re-hospitalization for cardiac causes)
Time Frame: From the enrollment to 1-year
Quality of life will be assess in the long-term impact of treatment strategy on symptoms, functional capacity and re-hospitalization for cardiac causes.
From the enrollment to 1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Luigi Gonzaga Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Actual)

September 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rivoli Hospital - aslTO3
  • AGECTO (Other Identifier: Rivoli Hospital - aslTO3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Non necessary

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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