Clinical trial NCT04429243: GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Stent-Graft Stenosis
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2020-06-12
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous (AV) access graft in Japan.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With Loss of Primary Patency of Target Lesion
timeFrame: up to 2 years
measure: Number of Subjects With Loss of Secondary Patency of Target Lesion
timeFrame: up to 2 years
measure: Number of Subjects With Loss of Primary Patency of Vascular Access Circuit
timeFrame: up to 2 years
measure: Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit
timeFrame: up to 2 years
measure: Mean Cumulative Number of Re-treatment Per Target Lesion
timeFrame: at 24 months
measure: Number of Subjects Achieving Technical Success
timeFrame: Day 1
measure: Number of Subjects Achieving Clinical Success
timeFrame: Day 1 to Month 1 follow up
measure: Number of Subjects Experiencing Device and Procedure-related Adverse Events
timeFrame: Day 1 to Month 1 follow up
measure: Number of Subjects Experiencing Device Defects
timeFrame: Day 1 to Month 1 follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Kaikoukai Central Clinic
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya Vascular Access Clinic
state: Aichi
city: Matsuyama
country: Japan
facility: Matsuyama Red Cross Hospital
state: Ehime
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa Cardiovascular Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Yokohama Dai-ichi Hospital
state: Kanagawa
city: Higashi
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
state: Kumamoto
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Aoi
country: Japan
facility: Shizuoka General Hospital
state: Shizuoka
city: Numazu
country: Japan
facility: Bouseidai1 Clinic
state: Shizuoka
city: Chiyoda
country: Japan
facility: Haruguchi Vascular Access Clinic
state: Tokyo
city: Musashino
country: Japan
facility: Kichijoji Asahi Hospital
state: Tokyo
city: Toshima
country: Japan
facility: Vascular Access Clinic Mejiro
state: Tokyo
city: Chuo
country: Japan
facility: University of Yamanashi Hospital
state: Yamanashi
city: Fukuoka
country: Japan
facility: Fukuoka City Hospital
city: Fukuoka
country: Japan
facility: Ikeda Vascular Access, Dialysis and Internal Medicine Clinic
city: Osaka
country: Japan
facility: Osaka Vascular Access Temma Nakamura Clinic
Study officials:
affiliation: W. L. Gore & Associates G.K
name: Kei Kaneko
role: STUDY_DIRECTOR
References: