N/A
N=60
Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA)
Popliteal Artery Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT02462876 ↗Enrolled (actual)
60
Serious AEs
53.3%
Results posted
Jul 2020
Primary outcome: Primary: Number of Subjects With Primary Patency at 12 Months — 40; 11 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- GORE® VIABAHN® Endoprosthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Primary Patency at 12 Months |
40; 11 | — |
| PRIMARY Number of Subjects With a Safety-related Event at 12 Months |
29; 27 | — |
| SECONDARY Probability of Primary Patency |
0.795; 0.734; 0.672 | — |
| SECONDARY Number of Subject With a Safety-related Event at 24 and 36 Months |
25; 29; 14; 34 | — |
| SECONDARY Length of Hospital Stay |
28; 16; 7; 9 | — |
| SECONDARY Length of Procedure |
112.5 | — |
| SECONDARY Probability of Primary Assisted Patency |
0.814; 0.732; 0.670 | — |
| SECONDARY Probability of Freedom From Limb Loss |
0.981; 0.981; 0.953 | — |
| SECONDARY Probability of Freedom From Repeat Intervention |
0.788; 0.788; 0.737 | — |
| SECONDARY Probability of Secondary Patency |
0.843; 0.822; 0.791 | — |
| SECONDARY Number of Subjects With Technical Success |
57; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
Inclusion to the study requires the patient:
- Received a GORE® VIABAHN® Endoprosthesis to treat a popliteal artery aneurysm
- 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;
- Was 18 years of age or older at the time of the treatment;
- Had an elective popliteal artery aneurysm procedure;
- 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:
- Bilateral popliteal artery aneurysms with initial treatment on the same day;
- Thrombotic occlusion of the popliteal artery or PAA;
- Marfan syndrome or Ehlers-Danlos syndrome;
- Unable to tolerate antiplatelet therapy;
- Thrombophilia requiring long term anticoagulation;
- Known allergies to the GORE® VIABAHN® Endoprosthesis components;
- 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.
Data sourced from ClinicalTrials.gov (NCT02462876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.