CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

SELUTION DeNovo Study is the largest DEB study ever initiated, involving up to 70 participating sites across 15 countries. Patients are randomized before any vessel preparation to reflect current medical practice and to reduce bias.  The objectives of the study are to demonstrate non-inferiority at both one and five years, and superiority for target vessel failure (TVF) at five years.

Vitestro expects to obtain CE marking by the end of 2024. The first 350 patients have currently been enrolled the A.D.O.P.T. (Autonomous Optimization and Performance Tests for Blood Testing) Trial at study site Result Laboratorium in the Albert Schweitzer Hospital. Investigational partners, in addition to Result Laboratorium – Albert Schweitzer Hospital, are St. Antonius, OLVG Lab and Amsterdam UMC.

The aim of the LOVE-DEB Study (Large de-NOVo coronary artEry disease treated with sirolimus Drug Eluting Balloon: prospective evaluation of safety & efficacy of SELUTION SLR drug eluting balloon) is to evaluate the safety and efficacy of SELUTION SLR in treating native de novo coronary artery disease in larger vessels (≥2.75mm). Its primary objective is to evaluate the proportion of patients who underwent Target Lesion Revascularization (TLR) within one year of their procedure.

“Gaining validation from the DSMB for the continued implementation of our proof-of-concept study is significant for SynerFuse, and we are thrilled about this milestone,” said SynerFuse co-founder, president, and CEO Justin Zenanko.

“The PINNACLE Clinical Trial Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia,” was authored by Dr. Steven A. Kaplan, professor of urology at the Icahn School of Medicine at Mount Sinai in New York and the principal investigator of the PINNACLE study.