Clinical

Clinical Trials

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: 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: Enrollment Completed

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

The Case Studies

Click on a case study below to see more information.

| Case Study| 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%

| Case Study| 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%

| Case Study| 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%

| Case Study| 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%

| Case Study| 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%

| Case Study| 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%

| Case Study| 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%

FLEX Posters, Abstracts, and Presentations

CVI 2018

To download the abstract, click here

To download the poster, click here

To download the presentation, click here

Charing Cross 2018 (Dr. Frank Arko Presentation)

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To download the presentation, click here

ISET 2018 - First Abstract

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To download the poster, click here

To download the presentation, click here

ISET 2018 - Second Abstract

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LINC 2018

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Other Posters, Abstracts, and Presentations

Swiss Vascular Society Meeting 2018

To download the poster, click here

NCVH 2018

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To download the presentation, click here

VASA 2018

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To download the poster, click here

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