TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Recruiting now

Conditions studied: Trans-femoral TAVI With Calcified Ilio-femoral Arteries

In brief

To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.

Key facts

Study ID

NCT05873842

Run by

Rede Optimus Hospitalar SA

People needed

50

Starts

2024-07-22

Expected to finish

2026-11-01

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• High-quality Contrast-enhanced ECG gated computed tomography (CT) scan of the heart, aorta and low-limb arteries
• Calcific severe PAD raising concerns within the Heart Team and judged as "arguable" for TF approach following angiography or CT-scan evaluation (hostile femoral access), with a RefD>/=5 mm and a MLD>/=3 mm.
• Hostility score >/= 23 in at least one segment of the axis under evaluation.

You may not qualify if…

• 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.
• Planned target limb major amputation (above the ankle).
• History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.
• Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
• Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Subject has known allergy to urethane, nylon, or silicone.
• Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
• Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
• The use of specialty balloons, re-entry or atherectomy devices

Where it is running

• AOU Cardiology Ancona — Ancona, Italy (enrolling)
• AULLS3 Cardiology Mestre — Mestre, Italy (enrolling)
• AOUI Cardiology Verona — Verona, Italy (enrolling)
• AULLS8 Cardiology Vicenza — Vicenza, Italy (enrolling)
• AULSS2 Cardiology Treviso — Treviso, Italy

Full record on ClinicalTrials.gov

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