TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Last updated: May 13, 2025
Sponsor: Rede Optimus Hospitalar SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Trans-femoral TAVI

Clinical Study ID

NCT05873842
RO-230301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 followingHeart 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 femoralaccess), 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

Exclusion Criteria:

  1. Life expectancy < 1 year

  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 thepast 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 performendovascular 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 investigationalagent (pharmaceutical, biologic, or medical device) that has not reached the primaryendpoint.

  11. 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.

  12. The use of specialty balloons, re-entry or atherectomy devices

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Trans-femoral TAVI
Phase:
Study Start date:
July 22, 2024
Estimated Completion Date:
November 01, 2026

Study Description

Trans-femoral (TF) access has been identified as the best vascular approach for trans-catheter aortic valve implantation (TAVI) in the most recent European Guidelines for the treatment of valvular heart disease. Nevertheless, the TF approach is not possible in a substantial number of TAVI candidates, mainly due to the presence of important peripheral arterial disease (PAD) that is perceived as a contraindication. The presence of PAD limiting TF-TAVI feasibility has always remained a challenging scenario. The concept of preparing TF access through balloon dilatation in case of PAD had been developed and, in this context, percutaneous transluminal angioplasty (PTA) with plain-balloon has been investigated, although available literature is scarce. Intra-vascular lithotripsy (IVL) was proved effective and safe to treat calcified peripheral arteries and such new technology bares the potential for being applied in TF TAVI in patients with concomitant PAD. The rationale is that the Shockwave IVL balloon inflated at low pressure modifies the vessel rigidity with creation of multiple longitudinal and transversal cracks in the calcium present within the vessel wall. Thus, the improved vessel compliance facilitates the successful passage of the valve delivery system resulting in higher rates of procedural success and lower risk for crossover to surgery, vessel injury and major complications.

Connect with a study center

  • AOU Cardiology Ancona

    Ancona,
    Italy

    Active - Recruiting

  • AULLS3 Cardiology Mestre

    Mestre,
    Italy

    Active - Recruiting

  • AULSS2 Cardiology Treviso

    Treviso,
    Italy

    Site Not Available

  • AOUI Cardiology Verona

    Verona,
    Italy

    Active - Recruiting

  • AULLS8 Cardiology Vicenza

    Vicenza,
    Italy

    Active - Recruiting

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