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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iliac | Subjects with de novo or restenotic lesions in the iliac arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
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| Superficial Femoral Artery (SFA) | Subjects with de novo or restenotic lesions in the SFA and proximal popliteal arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
| |
| Superficial Femoral Artery (SFA) In-Stent Restenosis (ISR) | Subjects with in-stent restenosis lesions in the SFA and proximal popliteal arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
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| AV access | Subjects with stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access graft and in the venous outflow of dialysis access circuits, including the central veins treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
| |
| Popliteal Artery Aneurysms |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients presenting with an indication for endovascular repair of one of the eight indications (iliac, SFA, SFA ISR, VAA, PAA, Trauma/Injury, AV access and others) are eligible for screening for participation in the registry. Only patients who meet all inclusion and no exclusion criteria, and who consent to participate will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Michel Reijnen, MD, PhD | Rijnstate Hospital, Arnhem, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| iD3 Medical cvba | Sint-Agatha-Berchem | 1082 | Belgium | |||
| Centre Hospitalier Unversitaire d'Angers |
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Subjects with popliteal artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
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| Trauma/Injury | Subjects with traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
|
| Visceral Artery Aneurysms | Subjects with isolated visceral artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
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| Others | Subjects treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) but do not fit any of the cohorts listed above. |
|
| 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 | 36 months |
| Primary patency for subjects treated in iliac | Blood flow through the target lesion without the need for repeat surgical or endovascular procedures | 60 months |
| Freedom from major amputation for subjects treated in iliac | No amputation above the level of the ankle of the treated index limb | 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 | 60 months |
| Freedom from major amputations for subjects treated in SFA de novo / restenotic and SFA ISR | No amputation above the level of the ankle of the treated index limb | 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 | 60 months |
| Freedom from death of any cause for subjects treated in Hemodialysis Access | Patient is free from death of any cause (is alive) | 60 months |
| Primary Patency for subjects treated in PAA | Blood flow through the target lesion without the need for repeat surgical or endovascular procedures | 120 months |
| Limb Salvage for subjects treated in PAA | Absence of an amputation above the level of the ankle of the index limb | 120 months |
| Primary Patency for subjects treated in VAA | Blood flow through the target lesion without the need for repeat surgical or endovascular procedures | 36 months |
| Device-related thrombosis for subjects treated in VAA | Stent thrombosis deemed to be device-related as assessed by the Investigator. | 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 | 12 months |
| Device-related thrombosis for subjects treated in Trauma-Injury | Stent thrombosis deemed to be device-related as assessed by the Investigator. | 12 months |
| Angers |
| 49933 |
| France |
| Centre Hospitalier Regional Universitaire de Brest | Brest | 29200 | France |
| Hopital Edouard Herriot (HCL) | Lyon | 69002 | France |
| Hospital Paris Saint-Joseph | Paris | 75014 | France |
| Clinique RHENA | Strasbourg | 67000 | France |
| Cardioangiologisches Centrum Bethanien | Frankfurt | 60389 | Germany |
| Marien Krankenhaus | Hamburg | 22087 | Germany |
| University of Heidelberg | Heidelberg | D-69120 | Germany |
| Krankenhaus Reinbek St. Adolf-Stift | Reinbek | 21465 | Germany |
| University Hospital Tuebingen | Tübingen | 72076 | Germany |
| Papageorgiou Hospital | Pávlos | 564 29 | Greece |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona | Ancona | 60127 | Italy |
| Fondazione Poliambulanza | Brescia | 25124 | Italy |
| S.C. Chirurgia Vascolare dell'A.O.U. di Modena | Modena | 41124 | Italy |
| Ospedale San Giovanni Molinette | Torino | 10126 | Italy |
| Dipartimento di Scienze Chirurgiche e Morfologiche | Varese | 21100 | Italy |
| Rijnstate | Arnhem | 6800 TA | Netherlands |
| Medical Center Leeuwarden | Leeuwarden | 8934 AD | Netherlands |
| Hospital Universitari Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Alvaro Cunqueiro Hospital | Vigo | 36213 | Spain |
| Skane University Hospital | Malmö | SE-205 02 | Sweden |
| Karolinska University Hospital | Solna | 171 64 | Sweden |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Greater Glasgow Health Board | Glasgow | G12 0XH | United Kingdom |
| Queen Elizabeth Hospital | London | SE18 4QH | United Kingdom |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000094622 | Popliteal Artery Aneurysm |
| D000081084 | Accidental Injuries |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D000783 | Aneurysm |
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