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 Type
OBSERVATIONAL
Enrollment
124
On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.
Kaikoukai Central Clinic
Nagoya, Aichi-ken, Japan
Nagoya Vascular Access Clinic
Nagoya, Aichi-ken, Japan
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at 24 months
Number of Subjects Achieving Technical Success
Technical Success is defined as \< 30% residual stenosis after initial treatment.
Time frame: Day 1
Number of Subjects Achieving Clinical Success
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Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan
Kansai Rosai Hospital
Amagasaki, Hyōgo, Japan
Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken, Japan
Yokohama Dai-ichi Hospital
Yokohama, Kanagawa, Japan
Japanese Red Cross Kumamoto Hospital
Higashi, Kumamoto, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Shizuoka General Hospital
Aoi, Shizuoka, Japan
Bouseidai1 Clinic
Numazu, Shizuoka, Japan
...and 7 more locations
Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment.
Time frame: Day 1 to Month 1 follow up
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.
Time frame: 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.
Time frame: Day 1 to Month 1 follow up