GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study

Completed

Conditions: Vascular Stent-Graft Stenosis

Interventions: Device: GORE® VIABAHN® Stent Graft

Registration Number: NCT04429243

Lead Sponsor: W.L.Gore & Associates

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 124

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

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GORE® VIABAHN® Stent Graft	GORE® VIABAHN® Stent Graft	Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Loss of Primary Patency of Target Lesion	up to 2 years	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.
Number of Subjects With Loss of Secondary Patency of Target Lesion	up to 2 years	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).
Number of Subjects With Loss of Primary Patency of Vascular Access Circuit	up to 2 years	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.
Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit	up to 2 years	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.
Mean Cumulative Number of Re-treatment Per Target Lesion	at 24 months	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.
Number of Subjects Achieving Technical Success	Day 1	Technical Success is defined as \< 30% residual stenosis after initial treatment.
Number of Subjects Achieving Clinical Success	Day 1 to Month 1 follow up	Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment.
Number of Subjects Experiencing Device and Procedure-related Adverse Events	Day 1 to Month 1 follow up	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.
Number of Subjects Experiencing Device Defects	Day 1 to Month 1 follow up	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (17): Haruguchi Vascular Access Clinic
🇯🇵
Chiyoda, Tokyo, Japan
Fukuoka City Hospital
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Fukuoka, Japan
Osaka Vascular Access Temma Nakamura Clinic
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Osaka, Japan
Ikeda Vascular Access, Dialysis and Internal Medicine Clinic
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Fukuoka, Japan
Nagoya Vascular Access Clinic
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Nagoya, Aichi, Japan
University of Yamanashi Hospital
🇯🇵
Chuo, Yamanashi, Japan
Japanese Red Cross Kumamoto Hospital
🇯🇵
Higashi, Kumamoto, Japan
Kichijoji Asahi Hospital
🇯🇵
Musashino, Tokyo, Japan
Kaikoukai Central Clinic
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Nagoya, Aichi, Japan
Shizuoka General Hospital
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Aoi, Shizuoka, Japan
Yokohama Dai-ichi Hospital
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Yokohama, Kanagawa, Japan
Saitama Medical Center
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Kawagoe, Saitama, Japan
Bouseidai1 Clinic
🇯🇵
Numazu, Shizuoka, Japan
Kansai Rosai Hospital
🇯🇵
Amagasaki, Hyogo, Japan
Kanazawa Cardiovascular Hospital
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Kanazawa, Ishikawa, Japan
Matsuyama Red Cross Hospital
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Matsuyama, Ehime, Japan
Vascular Access Clinic Mejiro
🇯🇵
Toshima, Tokyo, Japan