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Completed

NCT Number: NCT00737672

GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis

The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

Loading trial locations.

About this study

The primary effectiveness hypothesis is to demonstrate that the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface will extend the period of target lesion primary patency as compared to PTA.

The primary safety hypothesis is to demonstrate that the proportion of subjects remaining free from major device, procedure, and treatment site-related adverse events through 30 days post-procedure in the GORE® VIABAHN® Device group is not inferior to that of the PTA group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemodialysis patient with a dysfunctional or thrombosed forearm or upper arm prosthetic vascular access graft.
  • The target lesion starts less than or equal to 30 mm from the venous anastomosis.
  • The target lesion has > 50% stenosis as measured per protocol.
  • The patient has a maximum of one secondary stenosis.

Exclusion criteria

  • The age of the hemodialysis access graft is less than or equal to 30 days old from the date of the study procedure.
  • The patient has undergone an intervention (surgical or percutaneous) of the vascular access circuit less than or equal to 30 days from the date of the study procedure.
  • The secondary lesion is an occlusion.

Treatment and study plan

GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface

Device

Deployment of investigational stent graft at the venous anastomosis

Percutaneous Transluminal Angioplasty

Procedure

Percutaneous Transluminal Angioplasty at the venous anastomosis

Primary outcomes

  1. Target Lesion Primary Patency at 6 Months

    Time frame: 6 months

    Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.

    Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve.

  2. Target Lesion Primary Patency at 12 Months

    Time frame: 12 Months

    Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.

    Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve.

  3. Target Lesion Primary Patency at 24 Months

    Time frame: 24 Months

    Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.

    P-Value calculated from 24-month data cohort after study completion.

  4. Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure

    Time frame: 30 days

    The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.

Secondary outcomes

  1. Assisted Primary Patency at 6 Months

    Time frame: 6 months

    Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

    Six-month estimate of assisted primary patency derived from Kaplan-Meier curve.

  2. Assisted Primary Patency at 12 Months

    Time frame: 12 months

    Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

    Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve.

  3. Assisted Primary Patency at 24 Months

    Time frame: 24 months

    Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

    Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve.

  4. Access Secondary Patency at 6 Months

    Time frame: 6 months

    Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

    Six-month estimate of secondary access patency derived from Kaplan-Meier curve.

  5. Access Secondary Patency [12 Months] Units Percentage of Subjects

    Time frame: 12 months

    Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

    Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.

  6. Access Secondary Patency [24 Months] Units Percentage of Subjects

    Time frame: 24 months

    Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

    24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.

  7. Circuit Primary Patency

    Time frame: 6 months

    Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.

    P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve.

  8. Circuit Primary Patency [12 Months] Units Percentage of Subjects

    Time frame: 12months

    Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

    Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.

  9. Circuit Primary Patency [24 Months] Units Percentage of Subjects

    Time frame: 24 months

    Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

    Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.

  10. Clinical Success

    Time frame: Following Index Procedure

    The resumption of normal dialysis for at least one session following study treatment (Index Procedure).

  11. Anatomic Success

    Time frame: Index Procedure

    Less than 30 percent residual stenosis following study treatment (Index Procedure).

  12. Procedural Success

    Time frame: Following Index Procedure

    Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients

Acronym: REVISE

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Aug 19, 2008
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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