Trial Outcomes & Findings for Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA) (NCT NCT02462876)
NCT ID: NCT02462876
Last Updated: 2022-03-28
Results Overview
Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months.
COMPLETED
60 participants
12 months
2022-03-28
Participant Flow
Participant milestones
| Measure |
Viabahn
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Viabahn
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Surgical Bypass
|
9
|
|
Overall Study
Amputation Above the Metatarsals
|
1
|
|
Overall Study
36 months follow-up visit missed
|
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 contacted by phone but never came back for his follow-up visits
|
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
Patient cancelled the follow-up visit twice time
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
VIABAHN® Endoprosthesis
n=60 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 9.4 • n=60 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=60 Participants
|
|
Region of Enrollment
France
|
60 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Includes all subjects who lost patency within 12 months and all patent subjects with at least a 12 month visit or later.
Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months.
Outcome measures
| Measure |
Viabahn
n=51 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Number of Subjects With Primary Patency at 12 Months
Patent at 12 Months
|
40 Participants
|
|
Number of Subjects With Primary Patency at 12 Months
Not Patent
|
11 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
Safety-related events are defined as serious adverse events and adverse events related to the study procedure or the study device through 12 months
Outcome measures
| Measure |
Viabahn
n=56 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Number of Subjects With a Safety-related Event at 12 Months
No Event
|
29 Participants
|
|
Number of Subjects With a Safety-related Event at 12 Months
Event(s)
|
27 Participants
|
SECONDARY outcome
Timeframe: 12, 24, and 36 monthsPopulation: All participants are included in the Kaplan-Meier analysis for each time point.
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
Outcome measures
| Measure |
Viabahn
n=60 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Probability of Primary Patency
12 months
|
0.795 probability
Interval 0.661 to 0.881
|
|
Probability of Primary Patency
24 months
|
0.734 probability
Interval 0.592 to 0.834
|
|
Probability of Primary Patency
36 months
|
0.672 probability
Interval 0.514 to 0.788
|
SECONDARY outcome
Timeframe: 24 and 36 monthsPopulation: 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).
Safety-related events are defined as serious adverse events and adverse events related to study procedure or study device through 24 and 36 months.
Outcome measures
| Measure |
Viabahn
n=60 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Number of Subject With a Safety-related Event at 24 and 36 Months
24 months · No Event
|
25 Participants
|
|
Number of Subject With a Safety-related Event at 24 and 36 Months
24 months · Event(s)
|
29 Participants
|
|
Number of Subject With a Safety-related Event at 24 and 36 Months
36 months · No Event
|
14 Participants
|
|
Number of Subject With a Safety-related Event at 24 and 36 Months
36 months · Event(s)
|
34 Participants
|
SECONDARY outcome
Timeframe: During hospitalization, approximately 1-2 daysThe number of days the subject remains in the hospital due to endovascular repair of a popliteal artery aneurysm
Outcome measures
| Measure |
Viabahn
n=60 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Length of Hospital Stay
Days in Hospital = 1
|
28 Participants
|
|
Length of Hospital Stay
Days in Hospital = 2
|
16 Participants
|
|
Length of Hospital Stay
Days in Hospital = 3
|
7 Participants
|
|
Length of Hospital Stay
Days in Hospital = 4 or more
|
9 Participants
|
SECONDARY outcome
Timeframe: During procedure, approximately 120 minutesPopulation: Subjects with missing procedure times are not included.
The number of minutes the subject remains in the operating room or catheterization laboratory due to endovascular repair of a popliteal artery aneurysm.
Outcome measures
| Measure |
Viabahn
n=52 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Length of Procedure
|
112.5 minutes
Standard Deviation 39.0
|
SECONDARY outcome
Timeframe: 12, 24, and 36 monthsPopulation: All participants are included in the Kaplan-Meier analysis for each time point.
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.
Outcome measures
| Measure |
Viabahn
n=60 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Probability of Primary Assisted Patency
12 months
|
0.814 probability
Interval 0.681 to 0.895
|
|
Probability of Primary Assisted Patency
24 months
|
0.732 probability
Interval 0.589 to 0.832
|
|
Probability of Primary Assisted Patency
36 months
|
0.670 probability
Interval 0.512 to 0.787
|
SECONDARY outcome
Timeframe: 12, 24, and 36 monthsPopulation: All participants are included in the Kaplan-Meier analysis for each time point.
Limb loss is defined as the amputation of the study limb above the metatarsals. This outcome is estimated through Kaplan-Meier analysis.
Outcome measures
| Measure |
Viabahn
n=60 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Probability of Freedom From Limb Loss
12 months
|
0.981 probability
Interval 0.874 to 0.997
|
|
Probability of Freedom From Limb Loss
24 months
|
0.981 probability
Interval 0.874 to 0.997
|
|
Probability of Freedom From Limb Loss
36 months
|
0.953 probability
Interval 0.821 to 0.988
|
SECONDARY outcome
Timeframe: 12, 24, and 36 monthsPopulation: All participants are included in the Kaplan-Meier analysis for each time point.
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.
Outcome measures
| Measure |
Viabahn
n=60 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Probability of Freedom From Repeat Intervention
12 months
|
0.788 probability
Interval 0.657 to 0.874
|
|
Probability of Freedom From Repeat Intervention
24 months
|
0.788 probability
Interval 0.657 to 0.874
|
|
Probability of Freedom From Repeat Intervention
36 months
|
0.737 probability
Interval 0.593 to 0.837
|
SECONDARY outcome
Timeframe: 12, 24, and 36 monthsPopulation: All participants are included in the Kaplan-Meier analysis for each time point.
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.
Outcome measures
| Measure |
Viabahn
n=60 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Probability of Secondary Patency
12 months
|
0.843 probability
Interval 0.711 to 0.918
|
|
Probability of Secondary Patency
24 months
|
0.822 probability
Interval 0.685 to 0.903
|
|
Probability of Secondary Patency
36 months
|
0.791 probability
Interval 0.643 to 0.883
|
SECONDARY outcome
Timeframe: Post-procedure at day 30Population: Subjects who are not technical failures must have at least 31 days of follow-up in order to be considered a 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.
Outcome measures
| Measure |
Viabahn
n=58 Participants
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Number of Subjects With Technical Success
Success
|
57 Participants
|
|
Number of Subjects With Technical Success
Failure
|
1 Participants
|
Adverse Events
VIABAHN® Endoprosthesis
Serious adverse events
| Measure |
VIABAHN® Endoprosthesis
n=60 participants at risk
Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Blood and lymphatic system disorders
Anemia iron deficiency
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Cardiac disorders
Cardiac failure Nitric Oxide Synthases (NOS)
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Cardiac disorders
Coronaropathy
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
General disorders
Death
|
3.3%
2/60 • Number of events 2 • 36 months
|
|
General disorders
Endoleak
|
1.7%
1/60 • Number of events 2 • 36 months
|
|
General disorders
Oedema peripheral
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
General disorders
Vascular stent thrombosis
|
1.7%
1/60 • Number of events 2 • 36 months
|
|
Infections and infestations
Postoperative wound infection
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Infections and infestations
Renal cyst infection
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Infections and infestations
Sepsis
|
3.3%
2/60 • Number of events 2 • 36 months
|
|
Infections and infestations
Sinus infection
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
False aneurysm
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer metastatic
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Product Issues
Thrombosis in device
|
8.3%
5/60 • Number of events 6 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Skin and subcutaneous tissue disorders
Ankle ulcer
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Surgical and medical procedures
Aneurysm repair
|
1.7%
1/60 • Number of events 2 • 36 months
|
|
Surgical and medical procedures
Coronary Artery Bypass Graft (CABG)
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Surgical and medical procedures
Femoral-tibial arterial bypass
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Surgical and medical procedures
Femoropopliteal artery bypass
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Surgical and medical procedures
Nephrectomy
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Abdominal aneurysm
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Abdominal aneurysm, ruptured
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Abdominal aortic aneurysm
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Aneurysm enlargement
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Arteriovenous fistula
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Claudication
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Femoral artery aneurysm
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Femoral artery thrombosis
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Hematoma
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Iliac artery stenosis
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Intermittent claudication
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Ischaemic limb pain
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Ischemia
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Ischemia peripheral
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Ischemic limb pain
|
1.7%
1/60 • Number of events 1 • 36 months
|
|
Vascular disorders
Leg ischemia
|
3.3%
2/60 • Number of events 2 • 36 months
|
|
Vascular disorders
Peripheral artery aneurysm
|
3.3%
2/60 • Number of events 2 • 36 months
|
|
Vascular disorders
Peripheral ischaemia
|
3.3%
2/60 • Number of events 2 • 36 months
|
|
Vascular disorders
Popliteal artery aneurysm
|
1.7%
1/60 • Number of events 1 • 36 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place