IVUS Analysis for Coronary Obstruction in TAVI

NCT05164796 | Unknown DMC

• 1 other identifier: ICARO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Occlusion

Outcome Measures

Primary Outcomes (2)

• Incidence of IVUS assessement success

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

  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.

  Within the same 1 procedural day

Secondary Outcomes (4)

• CHIMNEY stenting rate

  Within the same 1 procedural day

• MACE

  1 month, 1 year.

• IVUS-angiography agreement rate

  Procedural 1 day

• Stent-optimization rate

  Procedural 1 day

Study Arms (1)

IVUS-guided

EXPERIMENTAL

Device: IVUS assessment of coronary ostia

Interventions

IVUS assessment of coronary ostia 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.

IVUS-guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• a. 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.
• b. 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universita di Verona: lead
• National University of Ireland, Galway, Ireland: collaborator

Study Sites (1)

AOUI Verona

Verona, 37100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 32894228 BACKGROUND

MeSH Terms

Conditions

Coronary Occlusion

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Flavio Ribichini, MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Darren Mylotte, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flavio Ribichini, MD

CONTACT

+39 045 812 2320; flavio.ribichini@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 21, 2021
• Study Start: January 20, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

IT (1)