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โ† Trials
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TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Recruitingn/aAges 18 Years - anyAllRede Optimus Hospitalar SA
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 of the heart, aorta and low-limb arteries 6. 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. 7. Hostility score \>/= 23 in at least one segment of the axis under evaluation. Exclusion Criteria: 1. Life expectancy \< 1 year 2. Subject has active infection requiring antibiotic therapy. 3. STS score โ‰ฅ8% 4. Leriche syndrome or other forms of total occlusion of the aorta or both iliac axes. 5. Planned target limb major amputation (above the ankle). 6. 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. 7. Subject in whom antiplatelet or anticoagulant therapy is contraindicated. 8. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. 9. Subject has known allergy to urethane, nylon, or silicone. 10. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. 11. 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. 12. The use of specialty balloons, re-entry or atherectomy devices
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What it tests

  • Trans-femoral TAVI
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Where

5 sites
AOU Cardiology Ancona
Ancona, Italy
AULLS3 Cardiology Mestre
Mestre, Italy
AULSS2 Cardiology Treviso
Treviso, Italy
AOUI Cardiology Verona
Verona, Italy
AULLS8 Cardiology Vicenza
Vicenza, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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