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IVUS Analysis for Coronary Obstruction in TAVI

NCT05164796 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-11-09

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • National University of Ireland, Galway, Ireland

    collaborator OTHER

  • Universita di Verona

    lead OTHER

Principal Investigators

  • Flavio Ribichini, MD · Universita di Verona

  • Darren Mylotte, MD, PhD · National University of Ireland Galway, Ireland. University College Hospital Galway, Ireland.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164796 on ClinicalTrials.gov