Aorto-iliac Occlusive Disease (AIOD), Isolated Artery Aneurysms (IAA), Trauma or Iatrogenic Vessel Injury, Visceral Artery Occlusive Disease (VAOD)
Conditions
Keywords
Peripheral Vascular Disease, Peripheral Arterial Disease, Aneurysm, Cardiovascular Disease, Trauma, Injury, Iliac, BXB, Aortoiliac occlusive disease, Visceral artery occlusive disease, Iliac arteries, visceral arteries, subclavian artery aneurysms, iatrogenic vessel injuries, FEVAR, BEVAR, CERAB
Brief summary
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
DEVICEReduced 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.
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Informed Consent Form (ICF) is signed by subject 3. Suitable for endovascular treatment with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) device 4. Willingness of the subject to adhere to institutional standard of care follow-up requirements
Exclusion criteria
1. 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). 2. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore. 3. Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. 4. Life expectancy \<12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites. 5. Known intolerance to anticoagulant and / or antiplatelet therapy at the time of the index procedure 6. 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. 7. Pregnant or breast-feeding subject at time of informed consent signature. 8. Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from device-related Serious Adverse Event (SAE) for patients treated with BXB device | within 30 days after the treatment | No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort |
| Procedural Success for patients treated with BXB device | at the time of implant | Successful access, delivery and deployment of BXB device, and withdrawal of catheters with patent BXB device at end of procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency for patients treated in Aortoiliac Occlusive Disease (AIOD) through 1 year follow-up | from the time of the index procedure up to 365 days (±window, between days 335 and 455) | Blood flow through the target vessel without the need for repeat surgical or endovascular procedures |
| Freedom from major amputation of the BXB device treated limb for patients treated in AIOD | from the time of the index procedure up to 365 days (±window, between days 335 and 455) | No amputation above the transmetatarsal level of the treated limb |
| Primary patency for patients treated in Visceral Occlusive Disease (VAOD) | from the time of the index procedure up to 365 days (±window, between days 335 and 455) | Blood flow through the target vessel without the need for repeat surgical or endovascular procedures |
| Survival for patients treated in VAOD | from the time of the index procedure up to 365 days (±window, between days 335 and 455) | Patient is free from death of any cause (is alive) |
| Freedom from reintervention through 1 year follow-up for patients treated in Isolated Artery Aneurysm (Subclavian, Visceral, Iliac) | from the time of the index procedure up to 365 days (±window, between days 335 and 455) | Freedom from unanticipated interventions on the target vessel(s) treated with the BXB Device. |
| 30 Day Mortality for patients treated in IAA | from the time of the index procedure through 30 days | all deaths, regardless of their relationship to the device, procedure, aneurysm, or unrelated medical conditions. |
| Treated vessel primary patency through 1 year follow-up for patients treated Trauma or Iatrogenic Vessel Injury | from the time of the index procedure up to 365 days (±window, between days 335 and 455) | Blood flow through the target vessel without the need for repeat surgical or endovascular procedures |
| Device-related adverse events (i.e. thrombosis) for patients treated in Trauma or or Iatrogenic Vessel Injury | from the time of the index procedure up to 365 days (±window, between days 335 and 455) | Stent thrombosis deemed to be device related as assessed by the Investigator. |
Countries
Germany
Contacts
CONTACTCagla Selvan
CONTACTValerie Jeans
PRINCIPAL_INVESTIGATORDaniele Branzan, Prof. Dr.
TUM Klinikum
Outcome results
None listed