VentureMed Group recently announced that it has completed enrollment of a randomized controlled trial (RCT) entitled “Flex Vessel Prep prior to PTA for the treatment of obstructive lesions in the native AVF.” This RCT was conducted to assess primary patency at six months when using Flex Vessel Prep system prior to percutaneous transluminal angioplasty (PTA) versus PTA alone for the treatment of obstructive lesions of native arteriovenous fistulas (AVFs) in the upper extremity.
The FLEX RCT was a prospective, multicenter, randomized study conducted at seven sites across the U.S. Seventy-five patients were enrolled and it includes 30-day, three-month, and six-month follow-up.
“Although fistula are the preferred access for hemodialysis, fistula dysfunction and failure remains a significant issue in AV dialysis access care. Balloon angioplasty considered the gold standard by most, still has its limitations due to the resistant and recurrent nature of these hyperplasic lesions, often requiring the use of high-pressure balloons,” said Sanford Altman, MD, from Open Access Vascular Access in Miami.
“These high-pressure balloon treatments can cause vessel wall damage accelerating restenosis and shortening the time between interventions. By utilizing the Flex Vessel Prep prior to angioplasty, we are hoping to see improved vessel compliance, reducing the need for high-pressure balloons while reducing the barotrauma to the vessel wall thereby extending the primary patency and time between interventions.”
“The rapid enrollment of these 75 patients at seven U.S. centers during a COVID-19 surge is encouraging”, said Denis Harrington, president and chief executive officer of the VentureMed Group. “We are excited to report our previous study, the FLEX AV Registry, will be presented at the VASA 2022 Symposium [June 9–11; Charleston, South Carolina]. 2022 is becoming a very impressive year for Flex Vessel Prep.”