Start Date: October 2019

Lead Investigator: John Aruny, MD

Investigator Location: Dialysis Access Institute – Orangeburg, South Carolina

Study Objective: To document the endovascular intervention approaches and outcomes when the FLEX Vessel Prep System is utilized in a hospital per the institution’s standard practice and at 6, 9, and 12 months following treatment.

Status: Recruiting

Start Date: May 2018

Lead Investigator: John Ross, MD, FACS

Investigator Location: Dialysis Access Institute – Orangeburg, South Carolina

Study Objective: To evaluate the safety and efficacy of the FLEX Vessel Prep™ System with a Drug Coated Balloon (DCB) in the maintenance of arteriovenous access sites with follow-up to 9 months.

Status: Complete

Start Date: October 2018

Lead Investigator: Louis Lopez, MD

Investigator Location: St Joseph’s Hospital – Fort Wayne, Indiana

Study Objective: To assess safety and efficacy of the FLEX Vessel Prep™ System in patients with atherosclerotic peripheral artery disease in the superficial femoral and popliteal arteries with follow-up to 1 year.

Status: Recruiting

Start Date: October 2018

Lead Investigator: Dr. Daniel Periard

Investigator Location: HFR- Hôpital Cantonal Fribourg – Fribourg, Switzerland

Study Objective: To evaluate the rate of lumen patency obtained by arterial preparation with the FLEX Vessel Prep™ System prior to conventional endovascular recanalization of the superficial femoral artery (SFA) and popliteal artery (PA) with follow-up to 1 year.

Status: Recruiting

Start Date: October 2019

Lead Investigator: Nicolas W. Shammas, MD

Investigator Location: Midwest Cardiovascular Research Foundation – Davenport, Iowa

Study Objective: To determine if the FLEX Vessel Prep™ System reduces dissections and the need for bailout stents in peripheral arteries.

Status: Complete