NCT05164796

IVUS Analysis for Coronary Obstruction in TAVI

Intravascular Ultrasound Assessment of Coronary Artery at High Risk for Obstruction Following TAVI

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universita di Verona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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CAO may occur on complete transcatheter heart valve (THV) deployment or after the protective coronary guidewire is withdrawn (3/5 of cases).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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-20
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2021-12-21
• Last updated: 2022-11-09

Locations

1 site across 1 country: Italy