GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study

GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study - Treatment of Patients With Stenosis or Occlusion at the Venous Anastomosis of Synthetic Arteriovenous (AV) Access Graft

This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft.

Study Overview

• Status: Completed
• Conditions: Vascular Stent-Graft Stenosis
• Intervention / Treatment: Device: GORE® VIABAHN® Stent Graft

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0046
    • Fukuoka City Hospital
  • Fukuoka, Japan
    • Ikeda Vascular Access, Dialysis and Internal Medicine Clinic
  • Osaka, Japan, 530-6012
    • Osaka Vascular Access Temma Nakamura Clinic
  • Aichi
    • Nagoya, Aichi, Japan, 454-0933
      • Kaikoukai Central Clinic
    • Nagoya, Aichi, Japan, 464-0850
      • Nagoya Vascular Access Clinic
  • Ehime
    • Matsuyama, Ehime, Japan, 790-8524
      • Matsuyama Red Cross Hospital
  • Hyogo
    • Amagasaki, Hyogo, Japan, 660-8511
      • Kansai Rosai Hospital
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-0007
      • Kanazawa Cardiovascular Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 220-0011
      • Yokohama Dai-ichi Hospital
  • Kumamoto
    • Higashi, Kumamoto, Japan, 861-8520
      • Japanese Red Cross Kumamoto Hospital
  • Saitama
    • Kawagoe, Saitama, Japan, 350-8550
      • Saitama Medical Center
  • Shizuoka
    • Aoi, Shizuoka, Japan, 420-8527
      • Shizuoka General Hospital
    • Numazu, Shizuoka, Japan, 410-0043
      • Bouseidai1 Clinic
  • Tokyo
    • Chiyoda, Tokyo, Japan, 102-0072
      • Haruguchi Vascular Access Clinic
    • Musashino, Tokyo, Japan, 180-0004
      • Kichijoji Asahi Hospital
    • Toshima, Tokyo, Japan, 171-0031
      • Vascular Access Clinic Mejiro
  • Yamanashi
    • Chuo, Yamanashi, Japan, 409-3898
      • University of Yamanashi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous (AV) access graft in Japan.

Description

Inclusion Criteria:

• Participants who developed stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
• Participants who was used to repair vascular access circuits for purposes other than treatment of stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GORE® VIABAHN® Stent Graft; Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation.	Device: GORE® VIABAHN® Stent Graft; On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Achieving Technical Success	Technical Success is defined as < 30% residual stenosis after initial treatment.	Day 1
Number of Subjects Achieving Clinical Success	Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment.	Day 1 to Month 1 follow up
Number of Subjects Experiencing Device Defects	A device defect is defined as a defect such as damage, malfunction, etc. that are widely unfavorable. Regardless of whether they are due to design, marketing, distribution, or use.	Day 1 to Month 1 follow up
Number of Subjects With Loss of Primary Patency of Target Lesion	Primary patency of target lesion is defined as the period during the patency was maintained from initial treatment until occlusion of target lesion or re-treatment of target lesion.	up to 2 years
Number of Subjects With Loss of Secondary Patency of Target Lesion	Secondary patency of target lesion is defined as the period during the patency was maintained from initial treatment (including the period of patency after re-treatment).	up to 2 years
Number of Subjects With Loss of Primary Patency of Vascular Access Circuit	Primary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until occlusion in vascular access or re-treatment in vascular access circuit.	up to 2 years
Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit	Secondary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until discontinuation of the use of vascular access circuit.	up to 2 years
Mean Cumulative Number of Re-treatment Per Target Lesion	Mean cumulative number of re-treatment in target lesion is defined as the number of re-treatment performed for target lesion after the initial treatment.	at 24 months
Number of Subjects Experiencing Device and Procedure-related Adverse Events	An adverse event (AE) is defined as any unfavorable or unintended sign (including abnormal laboratory changes), symptom, or illness associated with the use of a medical device. Unless worsening of severity or increasing of incidence during the surveillance, the primary disease of the patient is not considered an adverse event.	Day 1 to Month 1 follow up

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Study Director: Kei Kaneko, W. L. Gore & Associates G.K

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: JPS 19-05: AVR PMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes