TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRede Optimus Hospitalar SA
About this trial
To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.
Eligibility criteria
Qualifiers
Age > 18 years
Written informed consent
Diagnosis of symptomatic severe aortic stenosis
Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion.
Disqualifiers
Life expectancy < 1 year
Subject has active infection requiring antibiotic therapy.
STS score ≥8%
Leriche syndrome or other forms of total occlusion of the aorta or both iliac axes.
Trial design
Treatments tested in this trial
- Trans-femoral TAVI
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov