Hemodialysis Access, Peripheral Artery Disease, Popliteal Aneurysm, Trauma Injury, Visceral Artery Aneurysms
Conditions
Keywords
Viabahn, EVAR, Propaten, Iliac, SFA, SFA ISR, AV access, VAA, PAA, Trauma, Injury
Brief summary
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Detailed description
This is an Observational, prospective, single-arm, multicenter, post-market registry to collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) for one of the following indications: Iliac, Superficial Femoral Artery (SFA), Superficial Femoral Artery In-stent restenosis (SFA ISR), Hemodialysis access (AV access), Visceral artery aneurysms (VAA), Trauma/Injury, Popliteal Artery Aneurysms (PAA), or Other. Approximately 35 sites in Europe will participate and a minimum of 614 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) will be included and followed through one year for Trauma/Injury and other; three years for VAA; five years for Iliac, SFA, SFA ISR and AV access and ten years for PAA per institutional standard of care.
Interventions
DEVICEGORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Intent to treat with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Signed informed consent form 3. Suitable for endovascular treatment with VSX based on treating physician's best medical judgment 4. Willingness of the patient to adhere to institutional standard of care follow-up requirements
Exclusion criteria
1. Non-compliant lesions where full expansion of an angioplasty balloon catheter is not achievable during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. 2. Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis. 3. Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU). 4. Lesion requires treatment with an altered endoprosthesis or delivery system. (Do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system). 5. Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or patient requires enrollment into more than one cohort) (Note: Only the first VSX treatment will be enrolled if concurrent VSX procedures are performed that would require enrollment into more than one cohort). 6. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore. 7. Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. 8. Unable to tolerate antiplatelet therapy. 9. Patient has a non-controllable allergy to contrast or the VSX Device components. 10. Pregnant or breast-feeding female at time of informed consent signature. 11. Life expectancy \< 12 months due to comorbidities. 12. Patient has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Device-Related Serious Adverse Events (SAE) | 12 month | No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from death of any cause for subjects treated in Hemodialysis Access | 60 months | Patient is free from death of any cause (is alive) |
| Primary Patency for subjects treated in PAA | 120 months | Blood flow through the target lesion without the need for repeat surgical or endovascular procedures |
| Limb Salvage for subjects treated in PAA | 120 months | Absence of an amputation above the level of the ankle of the index limb |
| Primary Patency for subjects treated in VAA | 36 months | Blood flow through the target lesion without the need for repeat surgical or endovascular procedures |
| Device-related thrombosis for subjects treated in VAA | 36 months | Stent thrombosis deemed to be device-related as assessed by the Investigator. |
| Treated Lesion Primary patency for subjects treated in Trauma-Injury | 12 months | Blood flow through the target lesion without the need for repeat surgical or endovascular procedures |
| Device-related thrombosis for subjects treated in Trauma-Injury | 12 months | Stent thrombosis deemed to be device-related as assessed by the Investigator. |
| Freedom from Device-Related Serious Adverse Events (SAE) for patients treated specifically with PAHR09-13 | 36 months | Equivalent device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface devices with catalogue numbers PAHR09-13. No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort |
| Freedom from Target Lesion Revascularization (TLR) for patients treated specifically with PAHR09-13 | 36 months | Equivalent device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface devices with catalogue numbers PAHR09-13. No surgical or percutaneous revascularization procedure of the original treated lesion |
| Primary patency for subjects treated in iliac | 60 months | Blood flow through the target lesion without the need for repeat surgical or endovascular procedures |
| Freedom from major amputation for subjects treated in iliac | 60 months | No amputation above the level of the ankle of the treated index limb |
| Freedom from Target Lesion Revascularization (TLR) for subjects treated in SFA de novo / restenotic and SFA ISR | 60 months | No surgical or percutaneous revascularization procedure of the original treated lesion |
| Access secondary patency for subjects treated in Hemodialysis Access | 60 months | Blood flow through the original treated lesion with the use of an additional or secondary surgical or endovascular procedures after occlusion occurs, with freedom from device related abandonment. Secondary access patency is maintained if the patient can still dialyze through the access but has abandoned it for some other reason such as a transplant |
| Freedom from major amputations for subjects treated in SFA de novo / restenotic and SFA ISR | 60 months | No amputation above the level of the ankle of the treated index limb |
Countries
Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORMichel Reijnen, MD, PhD
Rijnstate Hospital, Arnhem, The Netherlands
Outcome results
None listed