Peripheral Artery Disease Clinical Trial
Official title:
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry
NCT number | NCT04907240 |
Other study ID # | VSX 20-03 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 9, 2021 |
Est. completion date | October 2035 |
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Status | Recruiting |
Enrollment | 614 |
Est. completion date | October 2035 |
Est. primary completion date | October 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Belgium | iD3 Medical cvba | Berchem-Sainte-Agathe | |
France | 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 | |
Germany | Cardioangiologisches Centrum Bethanien | Frankfurt | |
Germany | Marien Krankenhaus | Hamburg | |
Germany | University of Heidelberg | Heidelberg | |
Germany | Saarland University Medical Center | Homburg | |
Germany | Krankenhaus Reinbek St. Adolf-Stift | Reinbek | |
Germany | University Hospital Tuebingen | Tuebingen | |
Greece | Papageorgiou Hospital | Pavlos | |
Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona | Ancona | |
Italy | Fondazione Poliambulanza | Brescia | |
Italy | S.C. Chirurgia Vascolare dell'A.O.U. di Modena | Modena | |
Italy | Ospedale San Giovanni Molinette | Torino | |
Italy | Dipartimento di Scienze Chirurgiche e Morfologiche | Varese | |
Netherlands | Rijnstate | Arnhem | |
Netherlands | Medical Center Leeuwarden | Leeuwarden | |
Spain | Hospital Universitari Germans Trias i Pujol | Barcelona | |
Spain | Alvaro Cunqueiro Hospital | Vigo | |
Sweden | Skane University Hospital | Malmo | |
Sweden | Karolinska University Hospital | Solna | |
United Kingdom | Southmead Hospital | Bristol | |
United Kingdom | Greater Glasgow Health Board | Glasgow | |
United Kingdom | Queen Elizabeth Hospital | London |
Lead Sponsor | Collaborator |
---|---|
W.L.Gore & Associates |
Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Primary patency for subjects treated in iliac | Blood flow through the target lesion without the need for repeat surgical or endovascular procedures | 60 months | |
Secondary | Freedom from major amputation for subjects treated in iliac | No amputation above the level of the ankle of the treated index limb | 60 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Freedom from death of any cause for subjects treated in Hemodialysis Access | Patient is free from death of any cause (is alive) | 60 months | |
Secondary | Primary Patency for subjects treated in PAA | Blood flow through the target lesion without the need for repeat surgical or endovascular procedures | 120 months | |
Secondary | Limb Salvage for subjects treated in PAA | Absence of an amputation above the level of the ankle of the index limb | 120 months | |
Secondary | Primary Patency for subjects treated in VAA | Blood flow through the target lesion without the need for repeat surgical or endovascular procedures | 36 months | |
Secondary | Device-related thrombosis for subjects treated in VAA | Stent thrombosis deemed to be device-related as assessed by the Investigator. | 36 months | |
Secondary | 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 | |
Secondary | Device-related thrombosis for subjects treated in Trauma-Injury | Stent thrombosis deemed to be device-related as assessed by the Investigator. | 12 months |
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