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

• Sponsor: W.L.Gore & Associates (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02462876
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 62
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Popliteal Artery Aneurysm	Device: GORE® VIABAHN® Endoprosthesis

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Post-market Study: Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Dec 1, 2020

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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

2. 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.

3. 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

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpitaux Universitaire de Strasbourg	Strasbourg		France

Sponsors and Collaborators

• W.L.Gore & Associates

Investigators

• Principal Investigator: Nabil Chakfé, Hôpitaux Universitaire de Strasbourg

Study Documents (Full-Text)

• Study Protocol - Jul 14, 2015
• Statistical Analysis Plan - Jul 22, 2016

More Information

Publications

None provided.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT02462876
• Other Study ID Numbers: FPR14-03
• First Posted: Jun 4, 2015
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Aneurysm

Study Results

Participant Flow

Arm/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Period Title: Overall Study
STARTED	60
COMPLETED	33
NOT COMPLETED	27

Baseline Characteristics

Arm/Group Title	VIABAHN® Endoprosthesis
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Overall Participants	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.6 (9.4)
Sex: Female, Male (Count of Participants)
Female	2 3.3%
Male	58 96.7%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
France	60 100%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Primary Patency at 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Measure Participants	51
Patent at 12 Months	40 66.7%
Not Patent	11 18.3%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Measure Participants	56
No Event	29 48.3%
Event(s)	27 45%

3. Secondary Outcome

Title	Probability of Primary Patency
Description	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
Time Frame	12, 24, and 36 months

Outcome Measure Data

Analysis Population Description

All participants are included in the Kaplan-Meier analysis for each time point.

Arm/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Measure Participants	60
12 months	0.795
24 months	0.734
36 months	0.672

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Measure Participants	60
No Event	25 41.7%
Event(s)	29 48.3%
No Event	14 23.3%
Event(s)	34 56.7%

5. Secondary Outcome

Title	Length of Hospital Stay
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Measure Participants	60
Days in Hospital = 1	28 46.7%
Days in Hospital = 2	16 26.7%
Days in Hospital = 3	7 11.7%
Days in Hospital = 4 or more	9 15%

6. Secondary Outcome

Title	Length of Procedure
Description	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

Outcome Measure Data

Analysis Population Description

Subjects with missing procedure times are not included.

Arm/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Measure Participants	52
Mean (Standard Deviation) [minutes]	112.5 (39.0)

7. Secondary Outcome

Title	Probability of Primary Assisted Patency
Description	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.
Time Frame	12, 24, and 36 months

Outcome Measure Data

Analysis Population Description

All participants are included in the Kaplan-Meier analysis for each time point.

Arm/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Measure Participants	60
12 months	0.814
24 months	0.732
36 months	0.670

8. Secondary Outcome

Title	Probability of Freedom From Limb Loss
Description	Limb loss is defined as the amputation of the study limb above the metatarsals. This outcome is estimated through Kaplan-Meier analysis.
Time Frame	12, 24, and 36 months

Outcome Measure Data

Analysis Population Description

All participants are included in the Kaplan-Meier analysis for each time point.

Arm/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Measure Participants	60
12 months	0.981
24 months	0.981
36 months	0.953

9. Secondary Outcome

Title	Probability of Freedom From Repeat Intervention
Description	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.
Time Frame	12, 24, and 36 months

Outcome Measure Data

Analysis Population Description

All participants are included in the Kaplan-Meier analysis for each time point.

Arm/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Measure Participants	60
12 months	0.788
24 months	0.788
36 months	0.737

10. Secondary Outcome

Title	Probability of Secondary Patency
Description	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.
Time Frame	12, 24, and 36 months

Outcome Measure Data

Analysis Population Description

All participants are included in the Kaplan-Meier analysis for each time point.

Arm/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Measure Participants	60
12 months	0.843
24 months	0.822
36 months	0.791

11. Secondary Outcome

Title	Number of Subjects With Technical Success
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Viabahn
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
Measure Participants	58
Success	57 95%
Failure	1 1.7%

Adverse Events

Time Frame	36 months
Arm/Group Title	VIABAHN® Endoprosthesis
Arm/Group Description	Subjects with popliteal artery aneurysm treated with Gore Viabahn endoprosthesis
All Cause Mortality
	VIABAHN® Endoprosthesis
	Affected / at Risk (%)	# Events
Total	3/60 (5%)
Serious Adverse Events
	VIABAHN® Endoprosthesis
	Affected / at Risk (%)	# Events
Total	32/60 (53.3%)
Blood and lymphatic system disorders
Anemia	1/60 (1.7%)	1
Anemia iron deficiency	1/60 (1.7%)	1
Cardiac disorders
Cardiac failure Nitric Oxide Synthases (NOS)	1/60 (1.7%)	1
Cardio-respiratory arrest	1/60 (1.7%)	1
Coronaropathy	1/60 (1.7%)	1
General disorders
Death	2/60 (3.3%)	2
Endoleak	1/60 (1.7%)	2
Oedema peripheral	1/60 (1.7%)	1
Vascular stent thrombosis	1/60 (1.7%)	2
Infections and infestations
Postoperative wound infection	1/60 (1.7%)	1
Renal cyst infection	1/60 (1.7%)	1
Sepsis	2/60 (3.3%)	2
Sinus infection	1/60 (1.7%)	1
Injury, poisoning and procedural complications
False aneurysm	1/60 (1.7%)	1
Peripheral artery restenosis	1/60 (1.7%)	1
Pseudoaneurysm	1/60 (1.7%)	1
Vascular pseudoaneurysm	1/60 (1.7%)	1
Musculoskeletal and connective tissue disorders
Foot deformity	1/60 (1.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/60 (1.7%)	1
Pancreatic cancer metastatic	1/60 (1.7%)	1
Product Issues
Thrombosis in device	5/60 (8.3%)	6
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/60 (1.7%)	1
Acute respiratory failure	1/60 (1.7%)	1
Hemoptysis	1/60 (1.7%)	1
Respiratory insufficiency	1/60 (1.7%)	1
Skin and subcutaneous tissue disorders
Ankle ulcer	1/60 (1.7%)	1
Surgical and medical procedures
Aneurysm repair	1/60 (1.7%)	2
Coronary Artery Bypass Graft (CABG)	1/60 (1.7%)	1
Femoral-tibial arterial bypass	1/60 (1.7%)	1
Femoropopliteal artery bypass	1/60 (1.7%)	1
Nephrectomy	1/60 (1.7%)	1
Vascular disorders
Abdominal aneurysm	1/60 (1.7%)	1
Abdominal aneurysm, ruptured	1/60 (1.7%)	1
Abdominal aortic aneurysm	1/60 (1.7%)	1
Aneurysm enlargement	1/60 (1.7%)	1
Arteriovenous fistula	1/60 (1.7%)	1
Claudication	1/60 (1.7%)	1
Femoral artery aneurysm	1/60 (1.7%)	1
Femoral artery thrombosis	1/60 (1.7%)	1
Hematoma	1/60 (1.7%)	1
Iliac artery stenosis	1/60 (1.7%)	1
Intermittent claudication	1/60 (1.7%)	1
Ischaemic limb pain	1/60 (1.7%)	1
Ischemia	1/60 (1.7%)	1
Ischemia peripheral	1/60 (1.7%)	1
Ischemic limb pain	1/60 (1.7%)	1
Leg ischemia	2/60 (3.3%)	2
Peripheral artery aneurysm	2/60 (3.3%)	2
Peripheral ischaemia	2/60 (3.3%)	2
Popliteal artery aneurysm	1/60 (1.7%)	1
Other (Not Including Serious) Adverse Events
	VIABAHN® Endoprosthesis
	Affected / at Risk (%)	# Events
Total	0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.