Coronary Artery OcclusionICARONCT05164796
IVUS Analysis for Coronary Obstruction in TAVI
A study testing IVUS assessment of coronary ostia in people with Coronary Artery Occlusion, run by Universita di Verona at 1 site in Italy.
Trial summary
Observational, prospective, single-arm and multi-center study to assess the safety and feasibility of IVUS imaging in the setting of TAVI and to describe the angiographic and intravascular ultrasound features in patients with coronary arteries deemed at high-risk for coronary artery obstruction following TAVI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Occlusion
- What is being tested?
- IVUS assessment of coronary ostia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18 years
- Written informed consent
- Diagnosis of symptomatic severe aortic stenosis, or clinically relevant degeneration of previously implanted surgical aortic valve bioprosthesis
- Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion.
- High-quality ECG gated computed tomography (CT) scan of the heart and aorta
- Presence of 2 or more of the following risk factors for CAO (high-risk):
- 6a. TAVI in native valves: height of the coronary ostium (<9 mm), sinuses of Valsalva width <30 mm, leaflet tips extending above the coronary ostia or the sino-tubular junction.
- 6b. VIV-TAVI (patients undergoing BASILICA as first prevention strategy are also included): surgical bioprosthesis type: with supra-annular position, high leaflet profile, externally mounted leaflets stented valve, stentless valves, and bulky leaflets, low-lying coronary ostia (< 9 mm from the ostia to the sewing ring), narrow sinuses of Valsalva (<30 mm by width for Valsalva sinuses), virtual THV-coronary (VTC) distance <4 mm, virtual THV-STJ (VT-STJ) distance < 2.5-3.5 mm: to be considered in cases where VTC >4mm but the leaflet extends above or very close (up to 2mm below) to the STJ plane.
Who cannot join
- Age < 18 years
- Pregnancy
- Absence of informed consent
- Angiographic or functional critical stenosis of the at-risk coronary artery (%DS > 70 for right coronary artery, > 50 for left main, or positive functional assessment), requiring revascularization regardless the risk of CAO.
- Signs or symptoms of acute (unstable) myocardial ischemia
- Reduced survival expectancy due to severe co-morbidities (<1 year)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUI Verona
Verona, 37100
Flavio Ribichini, MD, +390458122320, clinica.cardiologica@aovr.veneto.it
About this study
Official title: Intravascular Ultrasound Assessment of Coronary Artery at High Risk for Obstruction Following TAVI
Observational, prospective, single-arm and multi-center study to assess the safety and feasibility of IVUS imaging in the setting of TAVI and to describe the angiographic and intravascular ultrasound features in patients with coronary arteries deemed at high-risk for coronary artery obstruction following TAVI.
Read the detailed description
CHIMNEY stenting is a reasonable strategy to manage catastrophic coronary artery obstruction (CAO). However, this technique is frequently used, not for acute catastrophic CAO (clinically evident), but preventively because the operator believes that CAO may occur on complete transcatheter heart valve (THV) deployment or after the protective coronary guidewire is withdrawn (3/5 of cases). Consequently, in current clinical practice, many patients receive CHIMNEY stents that are not required, and thus incur the associated risks of this procedure. To date, operators do not know how many patients, among those underwent preventive CHIMNEY, really required stenting, or on the contrary, did not. Also, accordingly, a real estimation of CAO incidence is not possible, but is likely higher than that reported in previous studies.
At present, no objective measures have been identified that could help operators decide when to deploy a CHIMNEY stent. If it could be demonstrated in the catheterization laboratory that the displaced native or bioprosthetic leaflets were sufficiently far away from the native coronary ostia and the risk for CAO was low, then unnecessary CHIMNEY stenting could be avoided.
Angiographic images do not provide sufficient information to clarify that. The investigation of a coronary ostium at risk of CAO from an intravascular point of view may reveal the presence of the displaced leaflet in front of them, or on the other hand, its absence, supporting operators in the decision to stent or not to stent.
In addition to the potential for IVUS to determine when CHIMNEY stenting should be used, this technique may also be used to optimize the results of CHIMNEY stenting when it has been deployed.
Moreover, IVUS can also be used to assess the result of the BASILICA technique after leaflet laceration.
The hypothesis is that the use of IVUS imaging for the assessment of patency of the coronary ostium and of the relationship of displaced valve leaflets towards the coronary arteries may reveal novel risk factors to predict which are not detectable by traditional angiography.
- Conditions
- Coronary Artery Occlusion
- Being tested
- IVUS assessment of coronary ostia
- Medical subject headings
- Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS assessment of coronary ostiaDevice
For coronary arteries at high-risk of obstruction during TAVI in native valves or valve-in-valve TAVI:
- IVUS analysis before valve implantation (+ coronary angiogram) to detect any leaflet interference with the coronary ostium, existing prior to the transcatheter heart valve (THV) placement
- IVUS analysis (+ coronary angiogram) after valve implantation in absence of acute coronary occlusion, to assess the patency of the ostium at-risk, the presence of native or degenerated surgical leaflet adjacent to the ostium, and the interaction of THV-frame with the coronary ostium.
- In case of CHIMNEY stenting, re-assessment of the stent expansion and coronary ostia patency with IVUS.
| Study group | Role | What they receive |
|---|---|---|
| IVUS-guided | Experimental | Not described Receives: Device: IVUS assessment of coronary ostia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of IVUS assessement success
Feasibility of IVUS assessement after the valve implantation (Yes, No)
Measured: Within the same 1 procedural day
Incidence of IVUS assessment-related adverse events
Safety of IVUS assessement. Composite of any clinical complication related to the attempted insertion of the IVUS catheter into the coronary artery, including: dissection, perforation, thrombosis, or flow impairment of the at-risk coronary or damage to the aortic wall or the THV during insertion of the IVUS catheter prior to or after TAVI.
Measured: Within the same 1 procedural day
Secondary outcomes (4)
CHIMNEY stenting rate
Comparison between the actual rate of CHIMNEY stenting performed after the final IVUS assessment, and the rate of potential CHIMNEY stenting reported by operators on the only basis of CT and angiography images (before IVUS assessment). This will provide information about the number of stents that could be "spared" because deemed useless after the more accurate IVUS study
Measured: Within the same 1 procedural day
MACE
Major Adverse Cardiovascular Events (MACE) occurred among patients treated with CHIMNEY stenting or with a deferred stent strategy at discharge, 30-day and 1-year follow-up
Measured: 1 month, 1 year.
IVUS-angiography agreement rate
The rate of agreement between angiography and IVUS evaluation of coronary ostia:
- rate of significant ostial stenosis as per angiography (%DS > 70 for RCA and > 50 for LM) vs IVUS assessment (lumen area < 4 mm2 for RCA and < 6 mm2 for LM).
- rate of leaflet footprint/floating mass detection by angiography vs IVUS
Measured: Procedural 1 day
Stent-optimization rate
The rate of stent optimization (post-dilatation or adjunctive stents) guided by IVUS assessment (only in stented coronaries)
Measured: Procedural 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start20 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery OcclusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Ireland, Galway, Ireland
- Responsible party
- Principal investigator, Flavio Ribichini, Universita di Verona
- Investigators
- Flavio Ribichini, MD, Principal investigator, Universita di VeronaDarren Mylotte, MD, PhD, Principal investigator, National University of Ireland Galway, Ireland. University College Hospital Galway, Ireland.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164796
- Sponsor's protocol ID
- ICARO
- Acronym
- ICARO
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pighi M, Lunardi M, Pesarini G, Castriota F, Venturi G, Gottin L, Scarsini R, Ferrero V, Ribichini FL. Intravascular ultrasound assessment of coronary ostia following valve-in-valve transcatheter aortic valve implantation. EuroIntervention. 2021 Feb 19;16(14):1148-1151. doi: 10.4244/EIJ-D-20-00611. No abstract available.
PubMed 32894228
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound Assessment of Coronary Artery at High Risk for Obstruction Following TAVI
- ClinicalTrials.gov ID
- NCT05164796
- Acronym / sponsor ID
- ICARO / ICARO
- Conditions
- Coronary Artery Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- National University of Ireland, Galway, Ireland
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Dec 2021 (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.
Observational, prospective, single-arm and multi-center study to assess the safety and feasibility of IVUS imaging in the setting of TAVI and to describe the angiographic and intravascular ultrasound features in patients with coronary arteries deemed at high-risk for coronary artery obstruction following TAVI.
Detailed description
CHIMNEY stenting is a reasonable strategy to manage catastrophic coronary artery obstruction (CAO). However, this technique is frequently used, not for acute catastrophic CAO (clinically evident), but preventively because the operator believes that CAO may occur on complete transcatheter heart valve (THV) deployment or after the protective coronary guidewire is withdrawn (3/5 of cases). Consequently, in current clinical practice, many patients receive CHIMNEY stents that are not required, and thus incur the associated risks of this procedure. To date, operators do not know how many patients, among those underwent preventive CHIMNEY, really required stenting, or on the contrary, did not. Also, accordingly, a real estimation of CAO incidence is not possible, but is likely higher than that reported in previous studies.
At present, no objective measures have been identified that could help operators decide when to deploy a CHIMNEY stent. If it could be demonstrated in the catheterization laboratory that the displaced native or bioprosthetic leaflets were sufficiently far away from the native coronary ostia and the risk for CAO was low, then unnecessary CHIMNEY stenting could be avoided.
Angiographic images do not provide sufficient information to clarify that. The investigation of a coronary ostium at risk of CAO from an intravascular point of view may reveal the presence of the displaced leaflet in front of them, or on the other hand, its absence, supporting operators in the decision to stent or not to stent.
In addition to the potential for IVUS to determine when CHIMNEY stenting should be used, this technique may also be used to optimize the results of CHIMNEY stenting when it has been deployed.
Moreover, IVUS can also be used to assess the result of the BASILICA technique after leaflet laceration.
The hypothesis is that the use of IVUS imaging for the assessment of patency of the coronary ostium and of the relationship of displaced valve leaflets towards the coronary arteries may reveal novel risk factors to predict which are not detectable by traditional angiography.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVUS-guided | Experimental | Device: IVUS assessment of coronary ostia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Written informed consent
- Diagnosis of symptomatic severe aortic stenosis, or clinically relevant degeneration of previously implanted surgical aortic valve bioprosthesis
- Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion.
- High-quality ECG gated computed tomography (CT) scan of the heart and aorta
Key exclusion criteria (6 listed)
- Age < 18 years
- Pregnancy
- Absence of informed consent
- Angiographic or functional critical stenosis of the at-risk coronary artery (%DS > 70 for right coronary artery, > 50 for left main, or positive functional assessment), requiring revascularization regardless the risk of CAO.
- Signs or symptoms of acute (unstable) myocardial ischemia
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 |
|---|---|---|
| IVUS assessment of coronary ostiaFor coronary arteries at high-risk of obstruction during TAVI in native valves or valve-in-valve TAVI: * IVUS analysis before valve implantation (+ coronary angiogram) to detect any leaflet interference with the coronary ostium, existing prior to the transcatheter heart valve (THV) placement * IVUS analysis (+ coronary angiogram) after valve implantation in absence of acute coronary occlusion, to assess the patency of the ostium at-risk, the presence of native or degenerated surgical leaflet adjacent to the ostium, and the interaction of THV-frame with the coronary ostium. * In case of CHIMNEY stenting, re-assessment of the stent expansion and coronary ostia patency with IVUS. | Device | IVUS-guided |
Primary outcome
Incidence of IVUS assessement success
Time frame: Within the same 1 procedural day
Feasibility of IVUS assessement after the valve implantation (Yes, No)
Incidence of IVUS assessment-related adverse events
Time frame: Within the same 1 procedural day
Safety of IVUS assessement. Composite of any clinical complication related to the attempted insertion of the IVUS catheter into the coronary artery, including: dissection, perforation, thrombosis, or flow impairment of the at-risk coronary or damage to the aortic wall or the THV during insertion of the IVUS catheter prior to or after TAVI.
4 secondary outcomes
CHIMNEY stenting rate
Time frame: Within the same 1 procedural day
MACE
Time frame: 1 month, 1 year.
IVUS-angiography agreement rate
Time frame: Procedural 1 day
Stent-optimization rate
Time frame: Procedural 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Background: PubMed 32894228Pighi M, Lunardi M, Pesarini G, Castriota F, Venturi G, Gottin L, Scarsini R, Ferrero V, Ribichini FL. Intravascular ultrasound assessment of coronary ostia following valve-in-valve transcatheter aortic valve implantation. EuroIntervention. 2021 Feb 19;16(14):1148-1151. doi: 10.4244/EIJ-D-20-00611. No abstract available.
- 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.
Flavio Ribichini, MD principal investigator
Universita di Verona
Darren Mylotte, MD, PhD principal investigator
National University of Ireland Galway, Ireland. University College Hospital Galway, Ireland.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS assessment of coronary ostia in people with Coronary Artery Occlusion, run by Universita di Verona at 1 site in Italy.
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 8 inclusion and 6 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 9 Nov 2022. 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 Italy. 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?
Contact Flavio Ribichini, MD (+39 045 812 2320, flavio.ribichini@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of IVUS assessement success (time frame: Within the same 1 procedural day). 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?
On the ClinicalTrials.gov record for NCT05164796, which also lists 1 linked publication.
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 9 Nov 2022.