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.
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