TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
NCT ID: NCT05873842
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-07-22
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PTA-assisted group
Trans-femoral TAVI
Trans-femoral TAVI (Trans-catheter Aortic Valve Implantation) with calcified ilio-femoral arteries via PTA (Percutaneous transluminal angioplasty ) or IVL (Intra-vascular Lithotripsy)
IVL-assisted group
Trans-femoral TAVI
Trans-femoral TAVI (Trans-catheter Aortic Valve Implantation) with calcified ilio-femoral arteries via PTA (Percutaneous transluminal angioplasty ) or IVL (Intra-vascular Lithotripsy)
Interventions
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Trans-femoral TAVI
Trans-femoral TAVI (Trans-catheter Aortic Valve Implantation) with calcified ilio-femoral arteries via PTA (Percutaneous transluminal angioplasty ) or IVL (Intra-vascular Lithotripsy)
Eligibility Criteria
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Inclusion Criteria
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
2. Subject has active infection requiring antibiotic therapy.
3. STS score ≥8%
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
18 Years
ALL
No
Sponsors
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Rede Optimus Hospitalar SA
NETWORK
Responsible Party
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Principal Investigators
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Flavio Ribichini, MD, PhD
Role: STUDY_DIRECTOR
AOUI, Verona
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RO-230301
Identifier Type: -
Identifier Source: org_study_id
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