Phase
Condition
N/ATreatment
Trans-femoral TAVI
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age > 18 years
Written informed consent
Diagnosis of symptomatic severe aortic stenosis
Patient undergoing TAVI according to local institutional protocol and followingHeart 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 femoralaccess), with a RefD>/=5 mm and a MLD>/=3 mm.
Hostility score >/= 23 in at least one segment of the axis under evaluation.
Exclusion
Exclusion Criteria:
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 thepast 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 performendovascular 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 investigationalagent (pharmaceutical, biologic, or medical device) that has not reached the primaryendpoint.
Subject has other medical, social or psychological problems that, in the opinion ofthe investigator, preclude them from receiving this treatment, and the proceduresand evaluations pre- and post-treatment.
The use of specialty balloons, re-entry or atherectomy devices
Study Design
Study Description
Connect with a study center
AOU Cardiology Ancona
Ancona,
ItalyActive - Recruiting
AULLS3 Cardiology Mestre
Mestre,
ItalyActive - Recruiting
AULSS2 Cardiology Treviso
Treviso,
ItalySite Not Available
AOUI Cardiology Verona
Verona,
ItalyActive - Recruiting
AULLS8 Cardiology Vicenza
Vicenza,
ItalyActive - Recruiting


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