TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Recruiting Observational Study
Trans-femoral TAVI With Calcified Ilio-femoral Arteries
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
Rede Optimus Hospitalar SA · Research network
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age \> 18 years 2. Written informed consent 3. Diagnosis of symptomatic severe aortic stenosis 4. Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion. 5. High-quality Contrast-enhanced ECG gated computed tomography (CT) scan o…
Contacts

Azinwi Phina Muna, phd

+49 157 80 58 5869

trafic@redeoptimus.com

CONTACT

Cristian Di Biase, Phd

+49 176 89982768

Cristian.dibiase@redeoptimus.com

CONTACT