VentureMed Group has announced the initiation of a new study to determine if the FLEX Dynamic Scoring Catheter reduces dissections and the need for bailout stents in peripheral arteries. The study entitled “Arterial Dissections Following FLEX Scoring and Adjunctive Balloon Angioplasty: Intravascular Ultrasound Assessment and Correlation with Angiographic Findings” will utilise intravascular ultrasound (IVUS) to identify the health of the vessel after treatment.
Nicolas W Shammas, founder and director of the Midwest Cardiovascular Research Foundation in Davenport, USA is the principal investigator for the study. This study is the second iDissection study performed by Shammas. The first study revealed that after atherectomy, in the peripheral arteries, significant dissections are more visible by a ratio of 6:1 when using IVUS in comparison to the typical angiogram. Deducing that the presence and severity of dissection after atherectomy may have been underestimated, especially for deeper dissections which are associated with recurrent restenosis, recoil, and possibly acute closure.
“After the indicative results of the initial iDissection study, I am motivated to look for vessel prep devices that further reduce the need for provisional stenting,” says Shammas. “I am optimistic about the ability of the FLEX Catheter to reduce the rate of high-grade dissections and looking forward to the evaluation.”
Using IVUS, the new study will evaluate the dissection rates of 15 patients following treatment of femoropopliteal de novo or no-stent restenosis by the FLEX Dynamic Scoring Catheter and plain old balloon angioplasty (POBA).