Clinical

Clinical Trials

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

Link To ClinicalTrials.gov

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: Active, Not Recruiting

Link To ClinicalTrials.gov

FORTEZ

Prospective Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the FLEX VP™ System plus DCB

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

Link To ClinicalTrials.gov

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

Link To ClinicalTrials.gov

FLEX iDissection

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

Start Date: October 2018

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

The Case Studies

Click on a case study below to see more information.

| AV Fistula - Case #86| Dr. Allen Lazenby

Dr. Allen Lazenby

East Alabama Medical Center
Opelika, AL
  • > Poor flow rate after previous interventions
  • > Pre-procedure stenosis: 95%
  • > Six passes with FLEX™, 20% lumen gain
  • > POBA full effacement at 6 atms
  • > Post-RX stenosis: 0%

| AV Fistula - Case #89| Dr. Allen Lazenby

Dr. Allen Lazenby

East Alabama Medical Center
Opelika, AL
  • > Poor flow rate after previous interventions
  • > Pre-procedure stenosis: 90%
  • > Seven passes with FLEX™: 15% lumen gain
  • > POBA full effacement at 8 atms
  • > Post-RX stenosis: 0%

| FemPop CTO - Case #313| Dr. Babatunde Oriowo

Dr. Babatunde Oriowo

Toledo Hospital
Toledo, OH
  • > 40 mm lesion in the SFA
  • > Pre-procedure stenosis of 100% (CTO)
  • > Four passes with FLEX™, 90% lumen gain
  • > Followed by POBA and DCB with full effacement at 4 atms
  • > Post-procedure stenosis of 0%

| FemPop SFA - Case #350| Dr. Daniel Ice

Dr. Daniel Ice

Deborah Heart and Lung
Browns Mills, NJ
  • > 10 mm lesion in the proximal SFA
  • > Pre-procedure stenosis of 80%
  • > 3 Passes with FLEX™, 50% lumen gain
  • > Followed by POBA and DCB, full effacement at 3 atms
  • > Post-procedure stenosis of 0%

| FemPop ISR - Case #360| Dr. Rajiv Swamy

Dr. Rajiv Swamy

West Penn Hospital
Pittsburgh, PA
  • > 30 mm lesion in the SFA. In-stent restenosis (ISR)
  • > Pre-procedure stenosis of 90%
  • > Three passes with FLEX™, lumen gain 30%
  • > Followed by 5 mm POBA with full effacement at 10 atms
  • > Post-procedure stenosis of 0%

| FemPop SFA - Case #342| Dr. Babatunde Oriowo

Dr. Babatunde Oriowo

Toledo Hospital
Toledo, OH
  • > 350 mm lesion in the SFA
  • > Pre-procedure stenosis of 99%
  • > Five passes with FLEX™, 59% lumen gain
  • > Followed by DCB with full effacement at 6 atms
  • > Post-procedure stenosis of 10%

| FemPop CTO - Case #332| Dr. Babatunde Oriowo

Dr. Babatunde Oriowo

Toledo Hospital
Toledo, OH
  • > 410 mm lesion along the entire SFA
  • > Pre-procedure stenosis of 100% (CTO)
  • > Four Passes with FLEX™, 50% lumen gain
  • > Followed by POBA and DCB with full effacement at 6 atms and 4 atms, respectively
  • > Post-procedure stenosis of 10%

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