Clinical Research Directory

The OSTIAL Study (Optimization of Stent Placement in Aorto-ostial Lesions)

Aorto-ostial coronary lesions present a significant challenge during coronary angioplasty. This is due to the difficulty of precisely identifying the aorto-ostial plane and the frequent instability of the guiding catheter during stent deployment. Despite the angiographic appearance being deemed optimal, several studies have shown a high rate of suboptimal stent positioning at the ostium when subsequent coronary CT angiography (CCTA) assessment is performed. This suboptimal positioning may be linked to incomplete ostial coverage, which could increase the risk of in-stent restenosis. It may also be linked to excessive stent protrusion into the aorta, which could compromise future procedures, particularly in the context of transcatheter aortic valve replacement. The "Floating Balloon" (FB) technique has been developed to improve system stability and to reliably mark the aorto-ostial landing zone (AOLZ). A previous study demonstrated the feasibility and accuracy of this technique. The aim of the current study is to assess the clinical effectiveness of the Floating Balloon. Although this technique is already in use, no study has yet conducted a systematic assessment of stent positioning using CCTA. The study utilised a combined retrospective-prospective approach to comprehensively evaluate the incidence of suboptimal stent positioning associated with the Floating Balloon technique. This evaluation was conducted by systematically comparing patient outcomes between those treated with the FB and those treated without the FB. The study employed CCTA as a key tool to assess stent position, ensuring a precise analysis of the data. To achieve this, it is recommended that follow-up data from patients who have already undergone the FB procedure and had their stent position assessed via CCTA (retrospective component) be analysed, while also enrolling new patients and randomizing them into FB and non-FB groups (prospective component).

Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH Feasibility Study)

This first in human feasibility study is designed to evaluate the feasibility MD-SBA DES in subjects undergoing percutaneous coronary intervention (PCI) to treat bifurcation lesions.

Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and/or neoatherosclerosis. International guidelines recommends non-compliant and very-high-pressure balloons, which lead to sub-optimal angiographic and clinical results. Recently, observational studies have suggested the feasibility and safety of intravascular lithotripsy (IVL) in UE treatment. There are no prospective randomised controlled studies comparing intravascular lithotripsy with balloons in ISR with UE.