Chronic Total Occlusion (CTO)CTO-VRNCT06728384
Remodeling of Distal Coronary Vessel in Chronic Total Occlusions: Prediction Based on Hemodynamic Coronary Parameters
An observational study of Chronic Total Occlusion (CTO) and Percutaneous Coronary Intervention (PCI), run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Background Revascularization of a chronic total occlusion (CTO) has gained popularity last decade. After recanalization there is an acute gain in vessel diameter, as well as a late lumen gain distal to the stent as a result of positive remodeling. The evolution of a recanalized CTO-vessel is however diverse. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Total Occlusion (CTO), Percutaneous Coronary Intervention (PCI), Fractional Flow Reserve
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Dec 2021to 28 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 30 patients scheduled for an elective revascularization procedure of a CTO and Heart-team consensus for the indication of a CTO treatment
Who may be able to join
- Scheduled elective revascularization procedure of a CTO, defined as a complete obstruction of a coronary artery with TIMI-0 or TIMI-1 flow and occlusion duration of at least 3 months
- Heart-team consensus for the indication of a CTO treatment, based on viability and ischemia testing (using TTE or MRI)
- Able to give valid, written informed consent
Who cannot join
- Unsuccessful crossing of the lesion during PCI
- Renal insufficiency defined as eGFR < 30 ml/min
- Contra-indications to intravenous adenosine
- < 18 years of age
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Background Revascularization of a chronic total occlusion (CTO) has gained popularity last decade. After recanalization there is an acute gain in vessel diameter, as well as a late lumen gain distal to the stent as a result of positive remodeling. The evolution of a recanalized CTO-vessel is however diverse. Several studies are performed to measure distal lumen gain and hemodynamic coronary parameters of a recanalized CTO, including the novel measurement Absolute Flow. Although the results seem promising, an association between those parameters and distal vessel lumen gain has never been found. The aim of this study is to understand the remodeling of the distal coronary vessel in relation with hemodynamic coronary parameters, establishing baseline predictive factors, adding new information about coronary physiology.
Objectives:
Read more
To establish baseline predictive factors for acute and late lumen growth after successful opening of chronic total occlusions. Secondary objectives are 1) Identifying the relation between change in absolute microvascular resistance and late change distal lumen diameter at the end of the index procedure and at 3 months follow-up, 2) Identifying the relation between late lumen growth and stent malapposition, assessed using Optical Coherence Tomography (OCT) and 3) Identifying the relation between angina-related symptoms, assessed using the Seattle Angina Questionnaire-7 (SAQ-7), and absolute microvascular resistance.
Hypothesis:
Acute and late lumen growth are dependent on preprocedural distal coronary artery perfusion pressure, decrease in microvascular resistance and growth of absolute antegrade flow. Late lumen growth predisposes for late stent malapposition.
Study design:
A single-center, prospective, observational cohort study. The center performing this study will be the Radboudumc.
Study Population:
30 patients scheduled for an elective revascularization procedure of a CTO and Heart-team consensus for the indication of a CTO treatment.
- Conditions
- Chronic Total Occlusion (CTO), Percutaneous Coronary Intervention (PCI), Fractional Flow Reserve, Quantitative Coronary Analysis, Absolute Flow Measurement, Optical Coherence Tomography (OCT)
- Keywords
- Chronic Total Occlusion, Percutaneous Coronary Intervention, Quantitative coronary analysis, Absolute flow measurement, Optical Coherence Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CTO patients undergoing FFR collateral, Absolute flow and OCT measurements | FFR collateral will be measured by measuring the wedge pressure distal from the occlusion, and after stent implantation by creating a balloon-over-the-wire occlusion. MLD will be measured with quantitative coronary analysis (QCA) Absolute flow will be measured by using a rayflow catheter with a pressure wire, and by using the Coroventis system. OCT will be performed during follow-up, using an OCT catheter and perform a pullback through the entire stent trajectory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute FFR collateral change
Changes in collateral function in rest and hyperaemic state, measured before recanalization and after recanalization
Measured: 30 minutes
Late FFR collateral change
Changes in collateral function in rest and hyperaemic state, measured after recanalization and at 3 months follow-up
Measured: 3 months
Acute MLD change
Changes in mean lumen diameter of the treated vessel, measured up to 5 mm distal to the occlusion before recanalization and distal to the stent after recanalization
Measured: 30 minutes
Late MLD change
Changes in mean lumen diameter of the treated vessel, measured up to 5 mm distal to the stent after recanalization and at 3 months follow-up
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start16 Dec 2021
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion (CTO)Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728384
- Sponsor's protocol ID
- 111578
- Acronym
- CTO-VR
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have planned to perform additional research on this topic.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remodeling of Distal Coronary Vessel in Chronic Total Occlusions: Prediction Based on Hemodynamic Coronary Parameters
- ClinicalTrials.gov ID
- NCT06728384
- Acronym / sponsor ID
- CTO-VR / 111578
- Conditions
- Chronic Total Occlusion (CTO), Percutaneous Coronary Intervention (PCI), Fractional Flow Reserve, Quantitative Coronary Analysis, Absolute Flow Measurement, Optical Coherence Tomography (OCT)
- Keywords
- Chronic Total Occlusion, Percutaneous Coronary Intervention, Quantitative coronary analysis, Absolute flow measurement, Optical Coherence Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 11 Dec 2024 (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.
Background Revascularization of a chronic total occlusion (CTO) has gained popularity last decade. After recanalization there is an acute gain in vessel diameter, as well as a late lumen gain distal to the stent as a result of positive remodeling. The evolution of a recanalized CTO-vessel is however diverse. Several studies are performed to measure distal lumen gain and hemodynamic coronary parameters of a recanalized CTO, including the novel measurement Absolute Flow. Although the results seem promising, an association between those parameters and distal vessel lumen gain has never been found. The aim of this study is to understand the remodeling of the distal coronary vessel in relation with hemodynamic coronary parameters, establishing baseline predictive factors, adding new information about coronary physiology.
Objectives:
To establish baseline predictive factors for acute and late lumen growth after successful opening of chronic total occlusions. Secondary objectives are 1) Identifying the relation between change in absolute microvascular resistance and late change distal lumen diameter at the end of the index procedure and at 3 months follow-up, 2) Identifying the relation between late lumen growth and stent malapposition, assessed using Optical Coherence Tomography (OCT) and 3) Identifying the relation between angina-related symptoms, assessed using the Seattle Angina Questionnaire-7 (SAQ-7), and absolute microvascular resistance.
Hypothesis:
Acute and late lumen growth are dependent on preprocedural distal coronary artery perfusion pressure, decrease in microvascular resistance and growth of absolute antegrade flow. Late lumen growth predisposes for late stent malapposition.
Study design:
A single-center, prospective, observational cohort study. The center performing this study will be the Radboudumc.
Study Population:
30 patients scheduled for an elective revascularization procedure of a CTO and Heart-team consensus for the indication of a CTO treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTO patients undergoing FFR collateral, Absolute flow and OCT measurements | – | –FFR collateral will be measured by measuring the wedge pressure distal from the occlusion, and after stent implantation by creating a balloon-over-the-wire occlusion. MLD will be measured with quantitative coronary analysis (QCA) Absolute flow will be measured by using a rayflow catheter with a pressure wire, and by using the Coroventis system. OCT will be performed during follow-up, using an OCT catheter and perform a pullback through the entire stent trajectory. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 30 patients scheduled for an elective revascularization procedure of a CTO and Heart-team consensus for the indication of a CTO treatment
Key inclusion criteria (3 listed)
- Scheduled elective revascularization procedure of a CTO, defined as a complete obstruction of a coronary artery with TIMI-0 or TIMI-1 flow and occlusion duration of at least 3 months
- Heart-team consensus for the indication of a CTO treatment, based on viability and ischemia testing (using TTE or MRI)
- Able to give valid, written informed consent
Key exclusion criteria (5 listed)
- Unsuccessful crossing of the lesion during PCI
- Renal insufficiency defined as eGFR < 30 ml/min
- Contra-indications to intravenous adenosine
- < 18 years of age
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute FFR collateral change
Time frame: 30 minutes
Changes in collateral function in rest and hyperaemic state, measured before recanalization and after recanalization
Late FFR collateral change
Time frame: 3 months
Changes in collateral function in rest and hyperaemic state, measured after recanalization and at 3 months follow-up
Acute MLD change
Time frame: 30 minutes
Changes in mean lumen diameter of the treated vessel, measured up to 5 mm distal to the occlusion before recanalization and distal to the stent after recanalization
Late MLD change
Time frame: 3 months
Changes in mean lumen diameter of the treated vessel, measured up to 5 mm distal to the stent after recanalization and at 3 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No. We have planned to perform additional research on this topic.
Related trials for Chronic Total Occlusion (CTO)
Not yet recruitingObservational study
Relationship Between Frontal QRS-T Angle and Collateral Circulation in Coronary Artery Chronic Total Occlusion
Chronic Total Occlusion (CTO), Frontal QRS-T Angle
Active, not recruiting
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
Chronic Total Occlusion of Coronary Artery
RecruitingObservational study
Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE)
RecruitingObservational study
TRIO CTO (Taiwan Research Initiative on Coronary Total Occlusion)
Chronic Total Occlusion (CTO)
Not yet recruiting
Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions
Angina (Stable), Coronary Occlusion
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.
1 site 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 (CTO) and Percutaneous Coronary Intervention (PCI), run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute FFR collateral change (time frame: 30 minutes). The study lists 4 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 11 Dec 2024.