GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorW.L.Gore & Associates

About this trial

Collect real-world post-market clinical follow-up data on subjects treated with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Informed Consent Form (ICF) is signed by subject

Suitable for endovascular treatment with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) device

Willingness of the subject to adhere to institutional standard of care follow-up requirements

Disqualifiers

Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or subject requires enrollment into more than one cohort) (Note: Only the first treatment will be enrolled if concurrent procedures are performed that would require enrollment into more than one cohort).

Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.

Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.

Life expectancy <12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites.

Trial population

The registry population will include subjects presenting with clinical conditions consistent with the BXB device indications for use and in accordance with standard of care. The following subject cohorts will be included in the registry: * Aortoiliac occlusive disease (AIOD) * Visceral artery occlusive disease VAOD) * Isolated visceral, iliac, and subclavian artery aneurysms \[IAA\] * 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) \[Arterial Injury (AI) * To satisfy a key objective of the PMCF plan, clinical data will be collected in other indications outside of those listed above (Other cohort) The registry has been designed with standard eligibility criteria to enroll subjects for which the registry device is intended to treat. Only subjects who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)

    Device

    This registry will collect data for eligible commercially available BXB device(s). The BXB device(s) will not be provided to the sites by the Sponsor. The BXB device implant procedure will be performed according to standard practice of the enrolling institution.

Treatment groups

240 Participants
are divided into 5 treatment groups
Group A: Aortoiliac Occlusive Disease: De novo or rest. lesions in the iliac arteries include aortic bifurcat1 intervention
Group B: Visceral Artery Occlusive Disease (VAOD): De novo or restenotic lesions in the visceral arteries1 intervention
Group C: Isolated Artery Aneurysmal Disease (IAA): Isolated visceral, iliac, and subclavian artery aneurysms1 intervention
Group D: Trauma or Iatrogenic Vessel Injury: are located in the chest cavity, abdominal cavity, or pelvis1 intervention
Group E: Other (subjects not fitting into the categories above)1 intervention

Trial outcomes

Primary outcomes

1

Freedom from device-related Serious Adverse Event (SAE) for patients treated with BXB device

No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort

Time frame
within 30 days after the treatment
2

Procedural Success for patients treated with BXB device

Successful access, delivery and deployment of BXB device, and withdrawal of catheters with patent BXB device at end of procedure

Time frame
at the time of implant

Secondary outcomes

1

Primary patency for patients treated in Aortoiliac Occlusive Disease (AIOD) through 1 year follow-up

Blood flow through the target vessel without the need for repeat surgical or endovascular procedures

Time frame
from the time of the index procedure up to 365 days (±window, between days 335 and 455)
2

Freedom from major amputation of the BXB device treated limb for patients treated in AIOD

No amputation above the transmetatarsal level of the treated limb

Time frame
from the time of the index procedure up to 365 days (±window, between days 335 and 455)
3

Primary patency for patients treated in Visceral Occlusive Disease (VAOD)

Blood flow through the target vessel without the need for repeat surgical or endovascular procedures

Time frame
from the time of the index procedure up to 365 days (±window, between days 335 and 455)
4

Survival for patients treated in VAOD

Patient is free from death of any cause (is alive)

Time frame
from the time of the index procedure up to 365 days (±window, between days 335 and 455)

Other outcomes

Sponsors and contacts

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