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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2024
Source W.L.Gore & Associates
Contact Alexandre Figard
Phone +33 6 08 02 42 91
Email afigard@wlgore.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)


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.


Recruitment information / eligibility

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).

Study Design


Intervention

Device:
GORE® 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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Greece,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

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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