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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.

Tracking Information
First Submitted Date  ICMJE June 12, 2018
First Posted Date  ICMJE June 25, 2018
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE May 29, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
  • Index of Patency Function [ Time Frame: 3, 6, 9 Months ]
    Index of Patency Function defined as the average time between interventions.
  • 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.
  • Number of Interventions [ Time Frame: 9 Months ]
    Mean cumulative interventions per subjects over study duration.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FLEX®-DCB Dialysis ACCESS Stenosis Study
Official Title  ICMJE FLEX®-DCB Dialysis ACCESS Stenosis Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arteriovenous Fistula
Intervention  ICMJE Combination Product: FLEX Scoring Catheter with Lutonix DCB
Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.
Study Arms  ICMJE 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).
Intervention: Combination Product: FLEX Scoring Catheter with Lutonix DCB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03566927
Other Study ID Numbers  ICMJE FLEX-DCB 0518-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VentureMed Group Inc.
Study Sponsor  ICMJE VentureMed Group Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account VentureMed Group Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP