Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA)

Post-market Study: Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02462876

Enrollment

Registered

2015-06-04

Start date

2015-10-31

Completion date

2020-12-31

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Popliteal Artery Aneurysm

Brief summary

This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.

Interventions

DEVICEGORE® VIABAHN® Endoprosthesis

Treatment of Popliteal Artery Aneurysm with the GORE® VIABAHN® Endoprosthesis.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion to the study requires the patient: 1. Received a GORE® VIABAHN® Endoprosthesis to treat a popliteal artery aneurysm 2. Had a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or the presence of mural thrombus (\< 2 cm) in the popliteal artery; 3. Was 18 years of age or older at the time of the treatment; 4. Had an elective popliteal artery aneurysm procedure; 5. Has provided Informed Consent, personally or through lawful representation as determined by applicable local regulations and state law

Exclusion criteria

Prior to or at the time of implant the patient is / has: 1. Bilateral popliteal artery aneurysms with initial treatment on the same day; 2. Thrombotic occlusion of the popliteal artery or PAA; 3. Marfan syndrome or Ehlers-Danlos syndrome; 4. Unable to tolerate antiplatelet therapy; 5. Thrombophilia requiring long term anticoagulation; 6. Known allergies to the GORE® VIABAHN® Endoprosthesis components; 7. Enrolled in another investigational drug or medical device trial where participation may have affected the outcome or treatment of the subject in the popliteal artery aneurysm study with the GORE® VIABAHN® Endoprosthesis or had previous surgery for the popliteal artery aneurysm in the study limb.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With Primary Patency at 12 Months	12 months	Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months.
Number of Subjects With a Safety-related Event at 12 Months	12 months	Safety-related events are defined as serious adverse events and adverse events related to the study procedure or the study device through 12 months

Secondary

Measure	Time frame	Description
Length of Hospital Stay	During hospitalization, approximately 1-2 days	The number of days the subject remains in the hospital due to endovascular repair of a popliteal artery aneurysm
Length of Procedure	During procedure, approximately 120 minutes	The number of minutes the subject remains in the operating room or catheterization laboratory due to endovascular repair of a popliteal artery aneurysm.
Probability of Primary Assisted Patency	12, 24, and 36 months	Primary assisted patency is defined as blood flow maintained through the device after implant regardless of repeat interventions performed (without occlusion). This outcome is estimated through Kaplan-Meier analysis.
Probability of Primary Patency	12, 24, and 36 months	Primary patency is defined as blood flow without occlusion maintained through the device after implant without an intervention. This outcome is estimated through Kaplan-Meier analysis
Probability of Freedom From Repeat Intervention	12, 24, and 36 months	Repeat Intervention is defined as any endovascular or surgical procedure performed to treat a stenosis or occlusion with the study device(s) or within 5 millimeters of the proximal or distal edge of the device(s), treatment of endoleaks or other reasons. This outcome is estimated through Kaplan-Meier analysis.
Probability of Secondary Patency	12, 24, and 36 months	Secondary patency is defined as blood flow through the device regardless of repeat interventions performed (with or without occlusion) and freedom from surgical bypass. This outcome is estimated through Kaplan-Meier analysis.
Number of Subjects With Technical Success	Post-procedure at day 30	Technical success is defined as successful aneurysmal exclusion using the study device at time of the procedure without Type I or III endoleaks that require post-procedure intervention within 30 days.
Probability of Freedom From Limb Loss	12, 24, and 36 months	Limb loss is defined as the amputation of the study limb above the metatarsals. This outcome is estimated through Kaplan-Meier analysis.
Number of Subject With a Safety-related Event at 24 and 36 Months	24 and 36 months	Safety-related events are defined as serious adverse events and adverse events related to study procedure or study device through 24 and 36 months.

Countries

France

Participant flow

Participants by arm

Arm	Count
VIABAHN® Endoprosthesis Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis	60
Total	60

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	36 months follow-up visit missed	1
Overall Study	Amputation Above the Metatarsals	1
Overall Study	Death	3
Overall Study	Lost to Follow-up	7
Overall Study	Patient cancelled the follow-up visit twice time	1
Overall Study	Patient contacted by phone but never came back for his follow-up visits	1
Overall Study	Patient did not come back since 4 months follow-up	1
Overall Study	Patient did not come back to the vascular department	1
Overall Study	Patient refused to come back	1
Overall Study	Patient was contacted on Sep 2020. He is fine but refused to come back for his 36 months	1
Overall Study	Surgical Bypass	9

Baseline characteristics

Characteristic	VIABAHN® Endoprosthesis	—
Age, Continuous	73.6 years STANDARD_DEVIATION 9.4	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment France	60 participants	—
Sex: Female, Male Female	2 Participants	—
Sex: Female, Male Male	58 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	3 / 60
other Total, other adverse events	0 / 60
serious Total, serious adverse events	32 / 60

Outcome results

Primary

Number of Subjects With a Safety-related Event at 12 Months

Safety-related events are defined as serious adverse events and adverse events related to the study procedure or the study device through 12 months

Time frame: 12 months

Population: Includes all subjects who have a serious adverse event or adverse event related to study procedure or device within 12 months and all subjects free from those events with at least a 12 month visit or later.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Viabahn	Number of Subjects With a Safety-related Event at 12 Months	No Event	29 Participants
Viabahn	Number of Subjects With a Safety-related Event at 12 Months	Event(s)	27 Participants

Primary

Number of Subjects With Primary Patency at 12 Months

Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months.

Time frame: 12 months

Population: Includes all subjects who lost patency within 12 months and all patent subjects with at least a 12 month visit or later.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Viabahn	Number of Subjects With Primary Patency at 12 Months	Patent at 12 Months	40 Participants
Viabahn	Number of Subjects With Primary Patency at 12 Months	Not Patent	11 Participants

Secondary

Length of Hospital Stay

The number of days the subject remains in the hospital due to endovascular repair of a popliteal artery aneurysm

Time frame: During hospitalization, approximately 1-2 days

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Viabahn	Length of Hospital Stay	Days in Hospital = 1	28 Participants
Viabahn	Length of Hospital Stay	Days in Hospital = 2	16 Participants
Viabahn	Length of Hospital Stay	Days in Hospital = 3	7 Participants
Viabahn	Length of Hospital Stay	Days in Hospital = 4 or more	9 Participants

Secondary

Length of Procedure

The number of minutes the subject remains in the operating room or catheterization laboratory due to endovascular repair of a popliteal artery aneurysm.

Time frame: During procedure, approximately 120 minutes

Population: Subjects with missing procedure times are not included.

Arm	Measure	Value (MEAN)	Dispersion
Viabahn	Length of Procedure	112.5 minutes	Standard Deviation 39

Secondary

Number of Subjects With Technical Success

Technical success is defined as successful aneurysmal exclusion using the study device at time of the procedure without Type I or III endoleaks that require post-procedure intervention within 30 days.

Time frame: Post-procedure at day 30

Population: Subjects who are not technical failures must have at least 31 days of follow-up in order to be considered a technical success.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Viabahn	Number of Subjects With Technical Success	Success	57 Participants
Viabahn	Number of Subjects With Technical Success	Failure	1 Participants

Secondary

Number of Subject With a Safety-related Event at 24 and 36 Months

Safety-related events are defined as serious adverse events and adverse events related to study procedure or study device through 24 and 36 months.

Time frame: 24 and 36 months

Population: For 24 month outcome, includes all subjects who have a serious adverse event or adverse event related to study procedure or device within 24 months and all subjects free from those events with at least a 24 month visit or later (54 subjects).~For 36 month outcome, includes all subjects who have a serious adverse event or adverse event related to study procedure or device within 36 months and all subjects free from those events with at least a 36 month visit or later (48 subjects).

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Viabahn	Number of Subject With a Safety-related Event at 24 and 36 Months	24 months	No Event	25 Participants
Viabahn	Number of Subject With a Safety-related Event at 24 and 36 Months	24 months	Event(s)	29 Participants
Viabahn	Number of Subject With a Safety-related Event at 24 and 36 Months	36 months	No Event	14 Participants
Viabahn	Number of Subject With a Safety-related Event at 24 and 36 Months	36 months	Event(s)	34 Participants

Secondary

Probability of Freedom From Limb Loss

Limb loss is defined as the amputation of the study limb above the metatarsals. This outcome is estimated through Kaplan-Meier analysis.