IVUS Analysis for Coronary Obstruction in TAVI

NCT ID: NCT05164796

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2024-12-31

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that CAO may occur on complete transcatheter heart valve (THV) deployment or after the protective coronary guidewire is withdrawn (3/5 of cases).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.

Conditions

Coronary Artery Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

IVUS-guided

Group Type: EXPERIMENTAL

IVUS assessment of coronary ostia

Intervention Type: DEVICE

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.

Interventions

IVUS assessment of coronary ostia

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role: collaborator

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Flavio Ribichini

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavio Ribichini, MD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Darren Mylotte, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Ireland Galway, Ireland. University College Hospital Galway, Ireland.

Locations

AOUI Verona

Verona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Flavio Ribichini, MD

Role: CONTACT

flavio.ribichini@univr.it

+39 045 812 2320

Facility Contacts

Flavio Ribichini, MD

Role: primary

clinica.cardiologica@aovr.veneto.it

+390458122320

References

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.

Reference Type: BACKGROUND

PMID: 32894228 (View on PubMed)

Other Identifiers

ICARO

Identifier Type: -

Identifier Source: org_study_id