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

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04907240
• Other study ID #: VSX 20-03
• Status: Recruiting
• Start date: October 9, 2021
• Est. completion date: October 2035

Study information

• Verified date: August 2023
• Source: W.L.Gore & Associates
• Contact: Alexandre Figard
• Phone: +33 6 08 02 42 91
• Email: afigard[@]wlgore.com
• Is FDA regulated: No
• 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).

Related Conditions & MeSH terms

• Aneurysm
• Hemodialysis Access
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Popliteal Aneurysm
• Popliteal Artery Aneurysm
• Trauma Injury
• Visceral Artery Aneurysms

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