Vascular Stent-Graft Stenosis Clinical Trial
Official title:
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study - Treatment of Patients With Stenosis or Occlusion at the Venous Anastomosis of Synthetic Arteriovenous (AV) Access Graft
| Verified date | October 2023 |
| Source | W.L.Gore & Associates |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 124 |
| Est. completion date | October 6, 2023 |
| Est. primary completion date | February 22, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Kansai Rosai Hospital | Amagasaki | Hyogo |
| Japan | Shizuoka General Hospital | Aoi | Shizuoka |
| Japan | Haruguchi Vascular Access Clinic | Chiyoda | Tokyo |
| Japan | University of Yamanashi Hospital | Chuo | Yamanashi |
| Japan | Fukuoka City Hospital | Fukuoka | |
| Japan | Ikeda Vascular Access, Dialysis and Internal Medicine Clinic | Fukuoka | |
| Japan | Japanese Red Cross Kumamoto Hospital | Higashi | Kumamoto |
| Japan | Kanazawa Cardiovascular Hospital | Kanazawa | Ishikawa |
| Japan | Saitama Medical Center | Kawagoe | Saitama |
| Japan | Matsuyama Red Cross Hospital | Matsuyama | Ehime |
| Japan | Kichijoji Asahi Hospital | Musashino | Tokyo |
| Japan | Kaikoukai Central Clinic | Nagoya | Aichi |
| Japan | Nagoya Vascular Access Clinic | Nagoya | Aichi |
| Japan | Bouseidai1 Clinic | Numazu | Shizuoka |
| Japan | Osaka Vascular Access Temma Nakamura Clinic | Osaka | |
| Japan | Vascular Access Clinic Mejiro | Toshima | Tokyo |
| Japan | Yokohama Dai-ichi Hospital | Yokohama | Kanagawa |
| Lead Sponsor | Collaborator |
|---|---|
| W.L.Gore & Associates |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Mean Cumulative Number of Re-treatment in 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. | up to 2 years | |
| Primary | Number of Subjects Achieving Technical Success | Technical Success is defined as < 30% residual stenosis after initial treatment. | Day 1 | |
| Primary | 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 | |
| Primary | Number of Subjects Experiencing 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 | |
| Primary | 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 |