Clinical trial NCT04907240: Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Official title: Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Artery Disease
Popliteal Aneurysm
Hemodialysis Access
Visceral Artery Aneurysms
Trauma Injury
Keywords: Viabahn
EVAR
Propaten
Iliac
SFA
SFA ISR
AV access
VAA
PAA
Trauma
Injury
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Freedom from Device-Related Serious Adverse Events (SAE)
timeFrame: 12 month
Secondary outcomes:
measure: Freedom from Device-Related Serious Adverse Events (SAE) for patients treated specifically with PAHR09-13
timeFrame: 36 months
measure: Freedom from Target Lesion Revascularization (TLR) for patients treated specifically with PAHR09-13
timeFrame: 36 months
measure: Primary patency for subjects treated in iliac
timeFrame: 60 months
measure: Freedom from major amputation for subjects treated in iliac
timeFrame: 60 months
measure: Freedom from Target Lesion Revascularization (TLR) for subjects treated in SFA de novo / restenotic and SFA ISR
timeFrame: 60 months
measure: Freedom from major amputations for subjects treated in SFA de novo / restenotic and SFA ISR
timeFrame: 60 months
measure: Access secondary patency for subjects treated in Hemodialysis Access
timeFrame: 60 months
measure: Freedom from death of any cause for subjects treated in Hemodialysis Access
timeFrame: 60 months
measure: Primary Patency for subjects treated in PAA
timeFrame: 120 months
measure: Limb Salvage for subjects treated in PAA
timeFrame: 120 months
measure: Primary Patency for subjects treated in VAA
timeFrame: 36 months
measure: Device-related thrombosis for subjects treated in VAA
timeFrame: 36 months
measure: Treated Lesion Primary patency for subjects treated in Trauma-Injury
timeFrame: 12 months
measure: Device-related thrombosis for subjects treated in Trauma-Injury
timeFrame: 12 months
Other outcomes:
Locations:
city: Berchem-Sainte-Agathe
country: Belgium
facility: iD3 Medical cvba
city: Angers
country: France
facility: Centre Hospitalier Unversitaire d'Angers
city: Brest
country: France
facility: Centre Hospitalier Regional Universitaire de Brest
city: Lyon
country: France
facility: Hopital Edouard Herriot (HCL)
city: Paris
country: France
facility: Hospital Paris Saint-Joseph
city: Strasbourg
country: France
facility: Clinique RHENA
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Hamburg
country: Germany
facility: Marien Krankenhaus
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Homburg
country: Germany
facility: Saarland University Medical Center
city: Reinbek
country: Germany
facility: Krankenhaus Reinbek St. Adolf-Stift
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
city: Pavlos
country: Greece
facility: Papageorgiou Hospital
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Modena
country: Italy
facility: S.C. Chirurgia Vascolare dell'A.O.U. di Modena
city: Torino
country: Italy
facility: Ospedale San Giovanni Molinette
city: Varese
country: Italy
facility: Dipartimento di Scienze Chirurgiche e Morfologiche
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Vigo
country: Spain
facility: Alvaro Cunqueiro Hospital
city: Malmo
country: Sweden
facility: Skane University Hospital
city: Solna
country: Sweden
facility: Karolinska University Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Glasgow
country: United Kingdom
facility: Greater Glasgow Health Board
city: London
country: United Kingdom
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Rijnstate Hospital, Arnhem, The Netherlands
name: Michel Reijnen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: