Explore
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: 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
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: Recruitment Completed
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: Recruitment Completed
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: Completed and presented at CIDA 2019
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:Completed and presented at CIDA 2019
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
VentureMed Group, Inc. develops and markets innovative endovascular medical devices to solve unmet medical needs in the treatment of PAD and stenoses of AV fistulas and grafts.
VentureMed Group, Inc. is a member of Medical Alley
VentureMed Group, Inc. develops and markets innovative endovascular medical devices to solve unmet medical needs in the treatment of PAD and stenoses of AV fistulas and grafts.
VentureMed Group, Inc. is a member of Medical Alley