Explore

FLEX CLINICALS

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: Recruiting

View Full Clinical Trial

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

View Full Clinical Trial

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

View Full Clinical Trial

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

View Full Clinical Trial

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

View Full Clinical Trial

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

View Full Clinical Trial

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

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