Actively Recruiting
TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
Led by Rede Optimus Hospitalar SA · Updated on 2025-05-16
50
Participants Needed
5
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.
CONDITIONS
Official Title
TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Written informed consent
- Diagnosis of symptomatic severe aortic stenosis
- Patient undergoing TAVI following local protocol and Heart Team discussion
- High-quality contrast-enhanced ECG gated CT scan of heart, aorta, and lower limb arteries
- Calcific severe PAD judged as "arguable" for transfemoral approach with RefD ≥ 5 mm and MLD ≥ 3 mm
- Hostility score ≥ 23 in at least one segment of the evaluated axis
You will not qualify if you...
- Life expectancy less than 1 year
- Active infection requiring antibiotic therapy
- STS score ≥ 8%
- Leriche syndrome or total occlusion of aorta or both iliac axes
- Planned major amputation above the ankle on target limb
- Prior or planned endovascular or surgical procedure on index limb within 30 days
- Contraindication to antiplatelet or anticoagulant therapy
- Known allergy to contrast agents or medications used in endovascular intervention that cannot be pre-treated
- Known allergy to urethane, nylon, or silicone
- Participation in another investigational study without primary endpoint reached
- Other medical, social, or psychological issues preventing treatment or evaluations
- Use of specialty balloons, re-entry, or atherectomy devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
AOU Cardiology Ancona
Ancona, Italy
Actively Recruiting
2
AULLS3 Cardiology Mestre
Mestre, Italy
Actively Recruiting
3
AULSS2 Cardiology Treviso
Treviso, Italy
Active, Not Recruiting
4
AOUI Cardiology Verona
Verona, Italy
Actively Recruiting
5
AULLS8 Cardiology Vicenza
Vicenza, Italy
Actively Recruiting
Research Team
A
Azinwi Phina Muna, phd
CONTACT
C
Cristian Di Biase, Phd
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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