Comparing two methods for improving access in heart valve procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness and safety of intravascular lithotripsy (IVL) versus balloon-only percutaneous transluminal angioplasty (PTA) for facilitating trans-femoral access in patients undergoing transcatheter aortic valve implantation (TAVI) with calcified ilio-femoral arteries. The study focuses on patients with significant peripheral arterial disease (PAD) that complicates the TF-TAVI approach. By using IVL, which creates cracks in the calcium of the vessel wall, the study seeks to improve vessel compliance and enhance procedural success rates while minimizing complications. The research is observational and will gather data from multiple centers to assess outcomes.

Why it matters

Who can join: the full rules

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 ≥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

Where it's running

• AOU Cardiology Ancona
  Ancona, Italy Recruiting
• AULLS3 Cardiology Mestre
  Mestre, Italy Recruiting
• AOUI Cardiology Verona
  Verona, Italy Recruiting
• AULLS8 Cardiology Vicenza
  Vicenza, Italy Recruiting
• AULSS2 Cardiology Treviso
  Treviso, Italy Active not recruiting

Study contacts

• Study coordinator: Azinwi Phina Muna, phd
• Email: trafic@redeoptimus.com
• Phone: +49 157 80 58 5869

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Shockwave technology for aortic repair procedures

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  Recruiting at 4 sites Rede Optimus Hospitalar SA · Münich, Bavaria and 4 other locations · NCT06332911

• Using Shockwave IVL with Drug-Coated Balloons for Calcified Lesions in Small Coronary Vessels

  This study is testing if using shockwave therapy with special drug-coated balloons can help people with hard-to-treat blockages in small coronary arteries feel better and improve their heart health.

  Recruiting at 2 sites Rede Optimus Hospitalar SA · São Paulo and 1 other locations · NCT05625997

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.