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

NCT07442526 | Active Not Recruiting

• 2 other identifiers: Rivoli Hospital - aslTO3AGECTO
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coronary Artery Disease (CAD); Chronic Total Occlusion (CTO); Optimal Medical Therapy; Percutaneous Coronary Intervention (PCI)

Keywords

Chronic Total Occlusion (CTO); Percutaneous Coronary Intervention (PCI); Optimal Medical Therapy (OMT); Octogenarians

Outcome Measures

Primary Outcomes (1)

• MACE (Major Cardiovascular Events)

  MACE is defined as a composite of all-cause mortality, non-fatal myocardial infarction, and repeat revascularization.

  From enrollment to 1-year

Secondary Outcomes (1)

• Quality of life (recurrent angina, dyspnea, re-hospitalization for cardiac causes)

  From the enrollment to 1-year

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Luigi Gonzaga Hospital: lead

Study Sites (1)

Rivoli Hospital

Rivoli, 10098, Italy

Location

Related Links

• Related Info

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: July 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)