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FLEX®-DCB Dialysis ACCESS Stenosis Study (AVAFLEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03566927
Recruitment Status : Active, not recruiting
First Posted : June 25, 2018
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
VentureMed Group Inc.

Brief Summary:
This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.

Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Combination Product: FLEX Scoring Catheter with Lutonix DCB Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FLEX®-DCB Dialysis ACCESS Stenosis Study
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

Arm Intervention/treatment
Experimental: FLEX Scoring Catheter plus DCB
This is a single-arm study. All patients will be treated with the FLEX Scoring Catheter, then a standard balloon angioplasty, followed by a Lutonix® drug-coated balloon (DCB).
Combination Product: FLEX Scoring Catheter with Lutonix DCB
Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.




Primary Outcome Measures :
  1. Target Lesion Primary Patency [ Time Frame: 9 Months ]
    Target Lesion Primary Patency at 9 months defined as the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.


Secondary Outcome Measures :
  1. Index of Patency Function [ Time Frame: 3, 6, 9 Months ]
    Index of Patency Function defined as the average time between interventions.

  2. Assess Secondary Patency [ Time Frame: 3, 6, 9 Months ]
    Assess Secondary Patency defined as the time interval from initial study treatment to abandonment of the vascular access circuit.

  3. Number of Interventions [ Time Frame: 9 Months ]
    Mean cumulative interventions per subjects over study duration.

  4. Percentage of Patients with Freedom from Adverse Events [ Time Frame: 1 Month ]
    Freedom from major device, procedure and treatment site-related adverse events through 30 days' post procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the informed consent form.
  • Arteriovenous fistula is located in the arm.
  • Native AV fistula / graft was created ≥ 30 days prior to the initial procedure and has undergone at least one hemodialysis sessions.
  • Venous stenosis of the AV fistula / graft with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.
  • Patients with a dysfunctional or thrombosed hemodialysis access and a >50% stenosis, regardless of prior treatment (All types of lesion and access failure)
  • If AV access is thrombosed, must undergo a successful thrombectomy with minimal residual thrombus.
  • Intended target lesion or if a tandem lesion can be treated with ≤120 mm of DCBs in length.

Exclusion Criteria:

  • Life expectancy < 9 months
  • Women who are pregnant, lactating, or planning on becoming pregnant during the duration of the study.
  • The hemodialysis access is located in the leg.
  • Patient has more than two lesions in the access circuit.
  • Patient has a secondary non-target lesion that cannot be successfully treated
  • Target lesion is located central to the axillosubclavian junction.
  • Surgical revision of the access site planned.
  • Recent surgical interventions of the access site.
  • Known allergy or sensitivity to iodinated contrast media, that cannot be adequately managed with pre- and post-procedure medication.
  • Known allergy or sensitivity to paclitaxel.
  • Patients who are taking immunosuppressive therapy, or routinely taking ≥ 10 mg of prednisone per day.
  • Patients who have a medical condition, in the opinion of the Investigator, that may cause the patient to be noncompliant to the protocol or confound the data.
  • Patients anticipating a kidney transplant.
  • Patients anticipating a conversion to peritoneal dialysis.
  • The patient has a stent located in the target or secondary non-target lesion.
  • Patient has an active infection in the AV access or a systemic infection.
  • Known hyper-coagulable state
  • Currently participating in an investigational drug, biologic, or device study.
  • Previously enrolled in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566927


Locations
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United States, South Carolina
Dialysis Access Institute
Orangeburg, South Carolina, United States, 29118
Sponsors and Collaborators
VentureMed Group Inc.
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Responsible Party: VentureMed Group Inc.
ClinicalTrials.gov Identifier: NCT03566927    
Other Study ID Numbers: FLEX-DCB 0518-2
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by VentureMed Group Inc.:
Arteriovenous Fistula
Vascular Fistula
Scoring
Fistula
Cardiovascular Disease
Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities