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

Hemodialysis Clinical Trial

— REVISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737672
• Other study ID #: AVR 06-01
• Secondary ID: G070069
• Status: Completed
• Phase: Phase 3
• First received: August 15, 2008
• Last updated: October 14, 2014
• Start date: September 2008
• Est. completion date: June 2013

Study information

• Verified date: October 2014
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: June 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis
• Renal Failure
• Renal Insufficiency

Intervention

Device:
• GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
Deployment of investigational stent graft at the venous anastomosis

Procedure:
• Percutaneous Transluminal Angioplasty
Percutaneous Transluminal Angioplasty at the venous anastomosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Primary Patency at 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.	6 months
Primary	Target Lesion Primary Patency at 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.	12 Months
Primary	Target Lesion Primary Patency at 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.	24 Months
Primary	Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure	The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.	30 days
Secondary	Assisted Primary Patency at 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.	6 months
Secondary	Assisted Primary Patency at 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.	12 months
Secondary	Assisted Primary Patency at 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.	24 months
Secondary	Access Secondary Patency at 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.	6 months
Secondary	Access Secondary Patency [12 Months] Units Percentage of Subjects	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.	12 months
Secondary	Access Secondary Patency [24 Months] Units Percentage of Subjects	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.	24 months
Secondary	Circuit Primary Patency	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.	6 months
Secondary	Circuit Primary Patency [12 Months] Units Percentage of Subjects	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.	12months
Secondary	Circuit Primary Patency [24 Months] Units Percentage of Subjects	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.	24 months
Secondary	Clinical Success	The resumption of normal dialysis for at least one session following study treatment (Index Procedure).	Following Index Procedure
Secondary	Anatomic Success	Less than 30 percent residual stenosis following study treatment (Index Procedure).	Index Procedure
Secondary	Procedural Success	Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.	Following Index Procedure