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Flex AV Registry
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: Completed – Moving to Publication
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:Completed – Moving to Publication



BELONG II
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: Completed – Moving to Publication



BELONG II
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: Completed – Moving to Publication



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: Completed and published1
- Shammas NW, Shammas WJ, Jones-Miller S, Radaideh Q, Shammas GA, Femoropliteal Arterial Dissections Post Flex Vessel Prep and Adjunctive Angioplasty: Results of the FLEX iDissection Study. J Invasive Cordiol. 2019 May; 31(5): 121-126



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: Completed and published1
- Shammas NW, Shammas WJ, Jones-Miller S, Radaideh Q, Shammas GA, Femoropliteal Arterial Dissections Post Flex Vessel Prep and Adjunctive Angioplasty: Results of the FLEX iDissection Study. J Invasive Cordiol. 2019 May; 31(5): 121-126