Post-Market Registry of the GOREĀ® VIABAHNĀ® VBX Balloon Expandable Endoprosthesis Implanted in Perā¦ (NCT03720704) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Post-Market Registry of the GOREĀ® VIABAHNĀ® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels
France, Germany, Italy280 participantsStarted 2018-12-18
Plain-language summary
The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GOREĀ® VIABAHNĀ® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require interventional treatment
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ā„ 18 years.
* Signed informed consent form
* Endovascular indication for treatment based on treating physician's best medical judgment.
* Intend for no other stents to be placed in the same peripheral vessel(s) targeted for VBX Stent Graft placement.
* Willingness of the patient to adhere to standard of care follow-up requirements.
Exclusion Criteria:
* Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
* Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
* Pregnant or breast-feeding female at time of informed consent signature.
* Life expectancy \< 12 months due to comorbidities.
* Use of the VBX Stent Graft is for the treatment of de novo iliac occlusive disease.
* Use of the VBX Stent Graft is for the treatment of aortic coarctations.
* Use of the VBX Stent Graft in the coronary, pulmonary, carotid, vertebral, isolated infrarenal aortic, or vena cava vessels.
What they're measuring
1
Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events