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IVUS Analysis for Coronary Obstruction in TAVI (ICARO)

Primary Purpose

Coronary Artery Occlusion

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
IVUS assessment of coronary ostia
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age > 18 years
  2. Written informed consent
  3. Diagnosis of symptomatic severe aortic stenosis, or clinically relevant degeneration of previously implanted surgical aortic valve bioprosthesis
  4. Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion.
  5. High-quality ECG gated computed tomography (CT) scan of the heart and aorta
  6. 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.

Exclusion Criteria:

  1. Age < 18 years
  2. Pregnancy
  3. Absence of informed consent
  4. 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.
  5. Signs or symptoms of acute (unstable) myocardial ischemia
  6. Reduced survival expectancy due to severe co-morbidities (<1 year)

Sites / Locations

  • AOUI VeronaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IVUS-guided

Arm Description

Outcomes

Primary Outcome Measures

Incidence of IVUS assessement success
Feasibility of IVUS assessement after the valve implantation (Yes, No)
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.

Secondary Outcome Measures

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
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
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
Stent-optimization rate
The rate of stent optimization (post-dilatation or adjunctive stents) guided by IVUS assessment (only in stented coronaries)

Full Information

First Posted
November 18, 2021
Last Updated
November 4, 2022
Sponsor
Universita di Verona
Collaborators
National University of Ireland, Galway, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT05164796
Brief Title
IVUS Analysis for Coronary Obstruction in TAVI
Acronym
ICARO
Official Title
Intravascular Ultrasound Assessment of Coronary Artery at High Risk for Obstruction Following TAVI
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
Collaborators
National University of Ireland, Galway, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Occlusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVUS-guided
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
IVUS assessment of coronary ostia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of IVUS assessement success
Description
Feasibility of IVUS assessement after the valve implantation (Yes, No)
Time Frame
Within the same 1 procedural day
Title
Incidence of IVUS assessment-related adverse events
Description
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.
Time Frame
Within the same 1 procedural day
Secondary Outcome Measure Information:
Title
CHIMNEY stenting rate
Description
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
Time Frame
Within the same 1 procedural day
Title
MACE
Description
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
Time Frame
1 month, 1 year.
Title
IVUS-angiography agreement rate
Description
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
Time Frame
Procedural 1 day
Title
Stent-optimization rate
Description
The rate of stent optimization (post-dilatation or adjunctive stents) guided by IVUS assessment (only in stented coronaries)
Time Frame
Procedural 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flavio Ribichini, MD
Phone
+39 045 812 2320
Email
flavio.ribichini@univr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavio Ribichini, MD
Organizational Affiliation
Universita di Verona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darren Mylotte, MD, PhD
Organizational Affiliation
National University of Ireland Galway, Ireland. University College Hospital Galway, Ireland.
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOUI Verona
City
Verona
ZIP/Postal Code
37100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavio Ribichini, MD
Phone
+390458122320
Email
clinica.cardiologica@aovr.veneto.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32894228
Citation
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.
Results Reference
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IVUS Analysis for Coronary Obstruction in TAVI

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