Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
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.
Study Type
OBSERVATIONAL
Enrollment
614
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.
iD3 Medical cvba
Sint-Agatha-Berchem, Belgium
Freedom from Device-Related Serious Adverse Events (SAE)
No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort
Time frame: 12 month
Freedom from Device-Related Serious Adverse Events (SAE) for patients treated specifically with PAHR09-13
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
Time frame: 36 months
Freedom from Target Lesion Revascularization (TLR) for patients treated specifically with PAHR09-13
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
Time frame: 36 months
Primary patency for subjects treated in iliac
Blood flow through the target lesion without the need for repeat surgical or endovascular procedures
Time frame: 60 months
Freedom from major amputation for subjects treated in iliac
No amputation above the level of the ankle of the treated index limb
Time frame: 60 months
Freedom from Target Lesion Revascularization (TLR) for subjects treated in SFA de novo / restenotic and SFA ISR
No surgical or percutaneous revascularization procedure of the original treated lesion
Time frame: 60 months
Freedom from major amputations for subjects treated in SFA de novo / restenotic and SFA ISR
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Centre Hospitalier Unversitaire d'Angers
Angers, France
Centre Hospitalier Regional Universitaire de Brest
Brest, France
Hopital Edouard Herriot (HCL)
Lyon, France
Hospital Paris Saint-Joseph
Paris, France
Clinique RHENA
Strasbourg, France
Cardioangiologisches Centrum Bethanien
Frankfurt, Germany
Marien Krankenhaus
Hamburg, Germany
University of Heidelberg
Heidelberg, Germany
Krankenhaus Reinbek St. Adolf-Stift
Reinbek, Germany
...and 16 more locations
No amputation above the level of the ankle of the treated index limb
Time frame: 60 months
Access secondary patency for subjects treated in Hemodialysis Access
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
Time frame: 60 months
Freedom from death of any cause for subjects treated in Hemodialysis Access
Patient is free from death of any cause (is alive)
Time frame: 60 months
Primary Patency for subjects treated in PAA
Blood flow through the target lesion without the need for repeat surgical or endovascular procedures
Time frame: 120 months
Limb Salvage for subjects treated in PAA
Absence of an amputation above the level of the ankle of the index limb
Time frame: 120 months
Primary Patency for subjects treated in VAA
Blood flow through the target lesion without the need for repeat surgical or endovascular procedures
Time frame: 36 months
Device-related thrombosis for subjects treated in VAA
Stent thrombosis deemed to be device-related as assessed by the Investigator.
Time frame: 36 months
Treated Lesion Primary patency for subjects treated in Trauma-Injury
Blood flow through the target lesion without the need for repeat surgical or endovascular procedures
Time frame: 12 months
Device-related thrombosis for subjects treated in Trauma-Injury
Stent thrombosis deemed to be device-related as assessed by the Investigator.
Time frame: 12 months