RecruitingNot Applicable

TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Italy50 participantsStarted 2024-07-22

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

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 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.

What they're measuring

Feasibility and safety on the trans-femoral (TF) approach

Timeframe: Index procedure - 1 Month

Trial details

NCT IDNCT05873842

SponsorRede Optimus Hospitalar SA

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2026-11-01

Contact for this trial

Azinwi Phina Muna, phd

+49 157 80 58 5869 trafic@redeoptimus.com

View on ClinicalTrials.gov More Trans-femoral TAVI With Calcified Ilio-femoral Arteries trials