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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE® VIABAHN® Stent Graft | Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® VIABAHN® Stent Graft | Device | On Day 1, participants will receive the GORE® VIABAHN® Stent Graft. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 Achieving Technical Success | Technical Success is defined as < 30% residual stenosis after initial treatment. |
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Inclusion Criteria:
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Patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous (AV) access graft in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Kei Kaneko | W. L. Gore & Associates G.K | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaikoukai Central Clinic | Nagoya | Aichi-ken | 454-0933 | Japan | ||
| Nagoya Vascular Access Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | GORE® VIABAHN® Stent Graft | Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation. GORE® VIABAHN® Stent Graft: On Day 1, participants will receive the GORE® VIABAHN® Stent Graft. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | GORE® VIABAHN® Stent Graft | Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation. GORE® VIABAHN® Stent Graft: On Day 1, participants will receive the GORE® VIABAHN® Stent Graft. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | up to 2 years |
|
|
Through 24 months (day 821)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GORE® VIABAHN® Stent Graft | Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation. GORE® VIABAHN® Stent Graft: On Day 1, participants will receive the GORE® VIABAHN® Stent Graft. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular stent occlusion | General disorders | MedDRA (26.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charee Robe | WL Gore | 9288644048 | crobe@wlgore.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2020 | Jul 1, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2023 | Jun 26, 2024 | SAP_001.pdf |
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| 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 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 |
| 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 |
| Nagoya |
| Aichi-ken |
| 464-0850 |
| Japan |
| Matsuyama Red Cross Hospital | Matsuyama | Ehime | 790-8524 | Japan |
| Kansai Rosai Hospital | Amagasaki | Hyōgo | 660-8511 | Japan |
| Kanazawa Cardiovascular Hospital | Kanazawa | Ishikawa-ken | 920-0007 | Japan |
| Yokohama Dai-ichi Hospital | Yokohama | Kanagawa | 220-0011 | Japan |
| Japanese Red Cross Kumamoto Hospital | Higashi | Kumamoto | 861-8520 | Japan |
| Saitama Medical Center | Kawagoe | Saitama | 350-8550 | Japan |
| Shizuoka General Hospital | Aoi | Shizuoka | 420-8527 | Japan |
| Bouseidai1 Clinic | Numazu | Shizuoka | 410-0043 | Japan |
| Haruguchi Vascular Access Clinic | Chiyoda City | Tokyo | 102-0072 | Japan |
| Kichijoji Asahi Hospital | Musashino | Tokyo | 180-0004 | Japan |
| Vascular Access Clinic Mejiro | Toshima City | Tokyo | 171-0031 | Japan |
| University of Yamanashi Hospital | Chūō | Yamanashi | 409-3898 | Japan |
| Fukuoka City Hospital | Fukuoka | 812-0046 | Japan |
| Ikeda Vascular Access, Dialysis and Internal Medicine Clinic | Fukuoka | Japan |
| Osaka Vascular Access Temma Nakamura Clinic | Osaka | 530-6012 | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoking History | Count of Participants | Participants |
|
|
|
| Primary | 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). | Posted | Count of Participants | Participants | up to 2 years |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | up to 2 years |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | up to 2 years |
|
|
|
| Primary | 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. | number of target lesions evaluable at 24 months | Posted | Mean | 95% Confidence Interval | reinterventions per target lesion | at 24 months | lesions | lesions |
|
|
|
| Primary | Number of Subjects Achieving Technical Success | Technical Success is defined as < 30% residual stenosis after initial treatment. | Evaluable subjects. Technical success could not be determined among 14 subjects not assessed for residual stenosis. | Posted | Count of Participants | Participants | 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. | Number of subjects with 1 month follow-up | Posted | Count of Participants | Participants | Day 1 to Month 1 follow up |
|
|
|
| Primary | 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. | subjects on study at 1 month | Posted | Count of Participants | Participants | 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. | Subjects on study at 1 month | Posted | Count of Participants | Participants | Day 1 to Month 1 follow up |
|
|
|
| 19 |
| 124 |
| 55 |
| 124 |
| 74 |
| 124 |
| Myocardial infarction | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
|
| Artificial blood vessel occlusion | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Vascular stent occlusion | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Vascular stent stenosis | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Contrast media allergy | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
|
| Arteriovenous graft site infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
|
| Infective spondylitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
|
| Shunt infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
|
| Arteriovenous graft site pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| Arteriovenous graft site stenosis | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
|
| Diabetic macroangiopathy | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
| Peripheral artery thrombosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
| Subclavian vein stenosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
| Venous occlusion | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
| Venous stenosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
|
| Vascular stent stenosis | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Arteriovenous graft site stenosis | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| Venous stenosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
The PI is required to obtain written permission from the Sponsor prior to publish trial results.