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FLEX CLINICALS
Clinical Studies

FLEX AV Registry
FLEX Arteriovenous Access Registry
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
Clinical Studies



FLEX AV Registry
FLEX Arteriovenous Access Registry
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



FLEX AV RCT
FLEX Vessel Prep Prior to the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
Start Date: November 2021
Physicians and Sites: Sanford Altman, MD – Miami, FL.
John Aruny, MD – Orangeburg, SC.
Jeff Hossut, MD –Raleigh, NC.
Neghae Maula, MD – Dallas, TX.
Study Objective: To evaluate and compare the serious adverse event rate at 30 days and primary patency at 6 months when using the FLEX Vessel Prep System prior to PTA vs. PTA alone
Status: Recruiting



FLEX AV RCT
FLEX Vessel Prep Prior to the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
Start Date: November 2021
Physicians and Sites: Sanford Altman, MD – Miami, FL; John Aruny, MD – Orangeburg, SC; Jeff Hossut, MD –Raleigh, NC; Neghae Maula, MD – Dallas, TX.
Study Objective: To evaluate and compare the serious adverse event rate at 30 days and primary patency at 6 months when using the FLEX Vessel Prep System prior to PTA vs. PTA alone
Status: Recruiting



AVAFLEX
FLEX – Drug Coated Balloon Dialysis ACCESS Stenosis Study
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



AVAFLEX
FLEX – Drug Coated Balloon Dialysis ACCESS Stenosis Study
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



BELONG
BEnefit of arterial preparation by LONGitudinal scoring before drug eluting balloon angioplasty of the superficial femoral and popliteal artery clinical study
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



BELONG
BEnefit of arterial preparation by LONGitudinal scoring before drug eluting balloon angioplasty of the superficial femoral and popliteal artery clinical study
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



FLEX iDissection
Arterial Dissections Following FLEX Scoring and Adjunctive Balloon Angioplasty: Intravascular Ultrasound Assessment and Correlation with Angiographic Findings
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



FLEX iDissection
Arterial Dissections Following FLEX Scoring and Adjunctive Balloon Angioplasty: Intravascular Ultrasound Assessment and Correlation with Angiographic Findings
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