Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
FLOW-CTO
Evolución de Las Resistencias Microvasculares y Del Flujo Coronario Absoluto en Pacientes Con intervención Coronaria percutánea de Una oclusión crónica
1 other identifier
observational
34
1 country
4
Brief Summary
It is an observational study which objective is to analyze, through a series of invasive parameters, the state of the coronary microvasculature immediately after the successful percutaneous coronary intervention of a chronic total occlusion and at 6 months after the index procedure. The aim of the study is to check the variation in the values of the index of microcirculatory resistance (IMR) and invasive absolute coronary flow (AF). The working hypothesis is that, in the follow-up of these patients, AF will increase significantly with respect to its baseline and, conversely, IMR will be reduced during the follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2020
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 5, 2022
CompletedFirst Posted
Study publicly available on registry
January 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedMarch 3, 2022
March 1, 2022
2 years
January 5, 2022
March 2, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Variation in the values of IMR between basal and 6-months follow-up
6 months
Variation in the values of absolute coronary flow between basal and 6-months follow-up
6 months
Study Arms (1)
Global cohort
Invasive coronary physiology parameters estimation, including: FFR, CFR, IMR, Absolute coronary flow (AF). AF derived resistances
Interventions
Estimation of guide-wire coronary physiology parameters
Eligibility Criteria
Patients with ischemic heart disease and evidence of at least one chronic total occlusion, with data of inducible ischemia and/or viability and susceptible to percutaneous coronary intervention.
You may qualify if:
- Those patients with a clinical indication for percutaneous coronary intervention of a chronic total occlusion. As a routine clinical practice in our center, it is proposed to perform a angiographic follow-up 6 months after the index procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hospital del Mar
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Puerta del Mar
Cadiz, Spain
Hospital Universitario de La Princesa
Madrid, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2022
First Posted
January 19, 2022
Study Start
October 1, 2020
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
March 3, 2022
Record last verified: 2022-03