GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry
Status
Conditions
Treatments
Details and patient eligibility
About
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)
Full 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.
Enrollment
Sex
Ages
Volunteers
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).
Trial design
240 participants in 5 patient groups
Trial contacts and locations
Loading...
Central trial contact
Cagla Selvan; Valerie Jeans
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal