Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry

Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry

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

Study Overview

• Status: Recruiting
• Conditions: Trauma Injury; Peripheral Artery Disease; Hemodialysis Access; Popliteal Aneurysm; Visceral Artery Aneurysms
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Estimated): 614

Contacts and Locations

• Study Contact: Name: Alexandre Figard; Phone Number: +33 6 08 02 42 91; Email: afigard@wlgore.com
• Study Contact Backup: Name: Susanne Fiedler; Phone Number: +49 174 777 4571; Email: sfiedler@wlgore.com

Study Locations

• Belgium
  • Berchem-Sainte-Agathe, Belgium, 1082
    • Recruiting
    • iD3 Medical cvba
    • Principal Investigator: Koen Deloose, MD
• France
  • Angers, France, 49933
    • Recruiting
    • Centre Hospitalier Unversitaire d'Angers
    • Principal Investigator: Jean Picquet, MD
  • Brest, France, 29200
    • Recruiting
    • Centre hospitalier régional universitaire de Brest
    • Principal Investigator: Bahaa Nasr, MD
  • Lyon, France, 69002
    • Recruiting
    • Hôpital Edouard Herriot (HCL)
    • Principal Investigator: Antoine Millon, MD
  • Paris, France, 75014
    • Recruiting
    • Hospital Paris Saint-Joseph
    • Principal Investigator: Yann Gouëffic, MD
  • Strasbourg, France, 67000
    • Recruiting
    • Clinique Rhéna
    • Principal Investigator: Gilles Goyault, MD
• Germany
  • Frankfurt, Germany, 60389
    • Recruiting
    • Cardioangiologisches Centrum Bethanien
    • Principal Investigator: Michael Piorkowski, MD
  • Hamburg, Germany, 22087
    • Recruiting
    • Marien Krankenhaus
    • Principal Investigator: Christian Habermann, MD
  • Heidelberg, Germany, D-69120
    • Recruiting
    • University of Heidelberg
    • Principal Investigator: Christian Erbel, MD
  • Homburg, Germany, D-66421
    • Withdrawn
    • Saarland University Medical Center
  • Reinbek, Germany, 21465
    • Recruiting
    • Krankenhaus Reinbek St. Adolf-Stift
    • Principal Investigator: Gerritt Krupski-Berdien, MD
  • Tuebingen, Germany, 72076
    • Recruiting
    • University Hospital Tuebingen
    • Principal Investigator: Gerd Groezinger, MD
• Greece
  • Pavlos, Greece, 564 29
    • Recruiting
    • Papageorgiou Hospital
    • Principal Investigator: Nikolaos Saratzis, MD
• Italy
  • Ancona, Italy, 60127
    • Recruiting
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
    • Principal Investigator: Luciano Carbonari, MD
  • Brescia, Italy, 25124
    • Recruiting
    • Fondazione Poliambulanza
    • Principal Investigator: Raffaello Bellosta, MD
  • Modena, Italy, 41124
    • Recruiting
    • S.C. Chirurgia Vascolare dell'A.O.U. di Modena
    • Principal Investigator: Roberto Silingardi, MD
  • Torino, Italy, 10126
    • Recruiting
    • Ospedale San Giovanni Molinette
    • Principal Investigator: Andrea Discalzi, MD
  • Varese, Italy, 21100
    • Recruiting
    • Dipartimento di Scienze Chirurgiche e Morfologiche
    • Principal Investigator: Gabriele Piffaretti, MD
• Netherlands
  • Arnhem, Netherlands, 6800 TA
    • Recruiting
    • Rijnstate
    • Principal Investigator: Michel Reijnen, MD
  • Leeuwarden, Netherlands, 8934 AD
    • Recruiting
    • Medical Center Leeuwarden
    • Principal Investigator: Laurens van Walraven, MD
• Spain
  • Barcelona, Spain, 08916
    • Recruiting
    • Hospital Universitari Germans Trias i Pujol
    • Principal Investigator: Secundino Llagostera Pujol, MD
  • Vigo, Spain, 36213
    • Recruiting
    • Álvaro Cunqueiro Hospital
    • Principal Investigator: Jorge Vidal Rey, MD
• Sweden
  • Malmo, Sweden, SE-205 02
    • Recruiting
    • Skane University Hospital
    • Principal Investigator: Nuno Dias, MD
  • Solna, Sweden, 171 64
    • Recruiting
    • Karolinska University Hospital
    • Principal Investigator: Joy Roy, MD
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Recruiting
    • Southmead Hospital
    • Principal Investigator: Peter Mezes, MD
  • Glasgow, United Kingdom, G12 0XH
    • Recruiting
    • Greater Glasgow Health Board
    • Principal Investigator: Ram Kasthuri, MD
  • London, United Kingdom, SE18 4QH
    • Recruiting
    • Queen Elizabeth Hospital
    • Principal Investigator: Robert Jones, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Iliac; Subjects with de novo or restenotic lesions in the iliac arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)	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.
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)	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.
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)	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.
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)	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.
Popliteal Artery Aneurysms; Subjects with popliteal artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)	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.
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)	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.
Visceral Artery Aneurysms; Subjects with isolated visceral artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)	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.
Others; Subjects treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) but do not fit any of the cohorts listed above.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Michel Reijnen, MD, PhD, Rijnstate hospital, Arnhem, The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2035

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Viabahn; Trauma; Injury; EVAR; SFA; Iliac; Propaten; SFA ISR; AV access; VAA; PAA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Aneurysm; Popliteal Artery Aneurysm
• Other Study ID Numbers: VSX 20-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO