Long-term Clinical Follow up After PCI for CTO

Completed

• Conditions: Coronary Total Occlusion
• Interventions: Other: Percutaneous Coronary Intervention of CTO

• Registration Number: NCT06544174
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

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 Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 463

Inclusion Criteria

• 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

Exclusion Criteria

• refusal of the patient to participate to the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Successful CTO-PCI	Percutaneous Coronary Intervention of CTO	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.

Primary Outcome Measures

Name	Time	Method
Major cardiovascular events (MACE)	Up to 8 years	Incidence of composite of cardiac death, non-fatal myocardial infarction and new target vessel revascularization

Secondary Outcome Measures

Name	Time	Method
Non combined MACE components	Up to 8 years	Incidence of Cardiac death, non-fatal myocardial infarction and new target vessel revascularization
Restenosis	Up to 8 years	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.
LVEF	Up to 8 years	Percentage of Increase or decrease in LVEF after the CTO procedure compared with baseline LVEF
In-hospital events	Up to one week	Incidence of Procedural complications including death, periprocedural MI, coronary perforation, pericardial tamponade requiring drainage, local vascular complications, major bleeding, contrast induced nephropathy, stroke
Ischemic burden	Up to 8 years	Comparison between pre and post-CTO ischemic tests
Stent thrombosis	Within 30 days after the procedure	Incidence of stent thrombosis defined as any myocardial infarction with angiographic confirmation of in-stent thrombus or unexplained death

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Montpellier, France