GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB).
- Who it may be relevant to
- Registry conditions: Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD), Isolated Artery Aneurysms (IAA), Trauma or Iatrogenic Vessel Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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)
Detailed description
This is a prospective, multicenter, observational registry to collect real world data of the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) device.
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:
* De novo or restenotic lesions in the iliac arteries including lesions at the aortic bifurcation \[Aortoiliac occlusive disease (AIOD)\], * De novo or restenotic lesions in the visceral arteries \[Visceral artery occlusive disease (VAOD)\], * Isolated visceral, iliac, and subclavian artery aneurysms \[IAA\], or * 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).
Approximately 24 clinical investigative sites in Europe, will participate in this registry. 240 subjects will be implanted in this study with a limit of 48 subjects treated / implanted per site. If a site reaches 48 subjects, enrolment will be closed for that site. All subjects will be followed through 12 months (1 year) post-procedure per standard of care. Quality of Life questionnaires will also be collected for all follow-up visits.
Interventions
- Device Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
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.
Primary outcome measures
- Freedom from device-related Serious Adverse Event (SAE) for patients treated with BXB device [Time frame: within 30 days after the treatment]
- Procedural Success for patients treated with BXB device [Time frame: at the time of implant]
Secondary outcome measures (8)
- Primary patency for patients treated in Aortoiliac Occlusive Disease (AIOD) through 1 year follow-up [Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
- Freedom from major amputation of the BXB device treated limb for patients treated in AIOD [Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
- Primary patency for patients treated in Visceral Occlusive Disease (VAOD) [Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
- Survival for patients treated in VAOD [Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
- Freedom from reintervention through 1 year follow-up for patients treated in Isolated Artery Aneurysm (Subclavian, Visceral, Iliac) [Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
- 30 Day Mortality for patients treated in IAA [Time frame: from the time of the index procedure through 30 days]
- Treated vessel primary patency through 1 year follow-up for patients treated Trauma or Iatrogenic Vessel Injury [Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
- Device-related adverse events (i.e. thrombosis) for patients treated in Trauma or or Iatrogenic Vessel Injury [Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
- Known intolerance to anticoagulant and / or antiplatelet therapy at the time of the index procedure
- Subject has a known allergy to contrast or the Reduced Profile VBX Stent (BXB) device components at the time of index procedure that cannot be adequately mitigated.
- Pregnant or breast-feeding subject at time of informed consent signature.
- Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- TUM Klinikum — Munich
Identifiers
NCT: NCT07279649 · VBX 22-08