Trial Outcomes & Findings for GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (NCT NCT04429243)

Last Updated: 2024-11-29

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

124 participants

Primary outcome timeframe

up to 2 years

Results posted on

2024-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	124
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GORE® VIABAHN® Stent Graft n=124 Participants 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.
Age, Continuous	71.8 years STANDARD_DEVIATION 11.6 • n=124 Participants
Sex: Female, Male Female	71 Participants n=124 Participants
Sex: Female, Male Male	53 Participants n=124 Participants
Region of Enrollment Japan	124 participants n=124 Participants
BMI	23.58 kg/m^2 STANDARD_DEVIATION 5.39 • n=124 Participants
Smoking History Currently Smoking	9 Participants n=124 Participants
Smoking History Past Smoking	10 Participants n=124 Participants
Smoking History No history of smoking	35 Participants n=124 Participants
Smoking History Unknown	70 Participants n=124 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GORE® VIABAHN® Stent Graft n=124 Participants 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.
Number of Subjects With Loss of Primary Patency of Target Lesion	81 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	GORE® VIABAHN® Stent Graft n=124 Participants 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.
Number of Subjects With Loss of Secondary Patency of Target Lesion	17 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GORE® VIABAHN® Stent Graft n=124 Participants 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.
Number of Subjects With Loss of Primary Patency of Vascular Access Circuit	98 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GORE® VIABAHN® Stent Graft n=124 Participants 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.
Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit	18 Participants

PRIMARY outcome

Timeframe: at 24 months

Population: number of target lesions evaluable 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.

Outcome measures

Outcome measures
Measure	GORE® VIABAHN® Stent Graft n=92 lesions 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.
Mean Cumulative Number of Re-treatment Per Target Lesion	2.052 reinterventions per target lesion Interval 1.601 to 2.502

PRIMARY outcome

Timeframe: Day 1

Population: Evaluable subjects. Technical success could not be determined among 14 subjects not assessed for residual stenosis.

Technical Success is defined as \< 30% residual stenosis after initial treatment.

Outcome measures

Outcome measures
Measure	GORE® VIABAHN® Stent Graft n=110 Participants 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.
Number of Subjects Achieving Technical Success	110 Participants

PRIMARY outcome

Timeframe: Day 1 to Month 1 follow up

Population: Number of subjects with 1 month follow-up

Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment.

Outcome measures

Outcome measures
Measure	GORE® VIABAHN® Stent Graft n=72 Participants 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.
Number of Subjects Achieving Clinical Success	72 Participants

PRIMARY outcome

Timeframe: Day 1 to Month 1 follow up

Population: subjects on study at 1 month

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.

Outcome measures

Outcome measures
Measure	GORE® VIABAHN® Stent Graft n=122 Participants 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.
Number of Subjects Experiencing Device and Procedure-related Adverse Events	4 Participants

PRIMARY outcome

Timeframe: Day 1 to Month 1 follow up

Population: Subjects on study at 1 month

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.

Outcome measures

Outcome measures
Measure	GORE® VIABAHN® Stent Graft n=122 Participants 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.
Number of Subjects Experiencing Device Defects	0 Participants

Adverse Events

GORE® VIABAHN® Stent Graft

Serious events: 55 serious events

Other events: 74 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	GORE® VIABAHN® Stent Graft n=124 participants at risk 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.
Cardiac disorders Cardiac failure	4.0% 5/124 • Number of events 5 • Through 24 months (day 821)
Cardiac disorders Myocardial infarction	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
General disorders Artificial blood vessel occlusion	4.0% 5/124 • Number of events 5 • Through 24 months (day 821)
General disorders Death	4.0% 5/124 • Number of events 5 • Through 24 months (day 821)
General disorders Vascular stent occlusion	16.1% 20/124 • Number of events 41 • Through 24 months (day 821)
General disorders Vascular stent stenosis	4.8% 6/124 • Number of events 9 • Through 24 months (day 821)
Immune system disorders Contrast media allergy	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
Infections and infestations Arteriovenous graft site infection	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
Infections and infestations Infective spondylitis	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
Infections and infestations Sepsis	1.6% 2/124 • Number of events 2 • Through 24 months (day 821)
Infections and infestations Shunt infection	2.4% 3/124 • Number of events 5 • Through 24 months (day 821)
Injury, poisoning and procedural complications Arteriovenous graft site pseudoaneurysm	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
Injury, poisoning and procedural complications Arteriovenous graft site stenosis	2.4% 3/124 • Number of events 5 • Through 24 months (day 821)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
Renal and urinary disorders Chronic kidney disease	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
Vascular disorders Diabetic macroangiopathy	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
Vascular disorders Peripheral arterial occlusive disease	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
Vascular disorders Peripheral artery thrombosis	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
Vascular disorders Shock haemorrhagic	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
Vascular disorders Subclavian vein stenosis	0.81% 1/124 • Number of events 3 • Through 24 months (day 821)
Vascular disorders Venous occlusion	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)
Vascular disorders Venous stenosis	3.2% 4/124 • Number of events 13 • Through 24 months (day 821)
Cardiac disorders Ventricular tachycardia	0.81% 1/124 • Number of events 1 • Through 24 months (day 821)

Other adverse events

Other adverse events
Measure	GORE® VIABAHN® Stent Graft n=124 participants at risk 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.
General disorders Vascular stent occlusion	31.5% 39/124 • Number of events 84 • Through 24 months (day 821)
General disorders Vascular stent stenosis	32.3% 40/124 • Number of events 98 • Through 24 months (day 821)
Injury, poisoning and procedural complications Arteriovenous graft site stenosis	16.9% 21/124 • Number of events 56 • Through 24 months (day 821)
Vascular disorders Venous stenosis	13.7% 17/124 • Number of events 34 • Through 24 months (day 821)

Additional Information

Charee Robe

WL Gore

Phone: 9288644048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI is required to obtain written permission from the Sponsor prior to publish trial results.
Publication restrictions are in place

Restriction type: OTHER