Chronic Total Occlusion of Coronary ArteryFLOW-CTONCT05197361
Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
An observational study of Chronic Total Occlusion of Coronary Artery and Microvascular Coronary Artery Disease, run by Parc de Salut Mar at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery, Microvascular Coronary Artery Disease, Coronary; Ischemic
- What is being tested?
- Invasive coronary physiology
- How many people
- 34 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Oct 2020to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- No specific exclusion criteria.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital del Mar
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Hospital Puerta del Mar
Cadiz
Hospital Universitario de La Princesa
Madrid
About this study
Official title: Evolución de Las Resistencias Microvasculares y Del Flujo Coronario Absoluto en Pacientes Con intervención Coronaria percutánea de Una oclusión crónica
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.
- Conditions
- Chronic Total Occlusion of Coronary Artery, Microvascular Coronary Artery Disease, Coronary; Ischemic, Coronary Microvascular Dysfunction
- Being tested
- Invasive coronary physiology
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive coronary physiologyDiagnostic test
Also called fractional flow reserve, coronary flow reserve, index of microvascular resistance, absolute coronary flow
Estimation of guide-wire coronary physiology parameters
| Study group | Role | What they receive |
|---|---|---|
| Global cohort | Invasive coronary physiology parameters estimation, including:
FFR, CFR, IMR, Absolute coronary flow (AF). AF derived resistances Receives: Diagnostic Test: Invasive coronary physiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in the values of IMR between basal and 6-months follow-up
Measured: 6 months
Variation in the values of absolute coronary flow between basal and 6-months follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Oct 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies 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
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197361
- Sponsor's protocol ID
- FLOW1
- Acronym
- FLOW-CTO
- Status last verified
- Mar 2022
- First submitted
- 5 Jan 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolución de Las Resistencias Microvasculares y Del Flujo Coronario Absoluto en Pacientes Con intervención Coronaria percutánea de Una oclusión crónica
- ClinicalTrials.gov ID
- NCT05197361
- Acronym / sponsor ID
- FLOW-CTO / FLOW1
- Conditions
- Chronic Total Occlusion of Coronary Artery, Microvascular Coronary Artery Disease, Coronary; Ischemic, Coronary Microvascular Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 19 Jan 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Global cohort | – | Diagnostic Test: Invasive coronary physiologyInvasive coronary physiology parameters estimation, including: FFR, CFR, IMR, Absolute coronary flow (AF). AF derived resistances |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- No specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive coronary physiologyAlso: fractional flow reserve, coronary flow reserve, index of microvascular resistance, absolute coronary flowEstimation of guide-wire coronary physiology parameters | Diagnostic test | Global cohort |
Primary outcome
Variation in the values of IMR between basal and 6-months follow-up
Time frame: 6 months
Variation in the values of absolute coronary flow between basal and 6-months follow-up
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Total Occlusion of Coronary Artery and Microvascular Coronary Artery Disease, run by Parc de Salut Mar at 4 sites in Spain.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Results are not available in the source record.
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?
Variation in the values of IMR between basal and 6-months follow-up (time frame: 6 months). The study lists 2 primary outcomes in all. 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 3 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.