Comparing two methods for improving access in heart valve procedures

TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

This study is testing whether a new method using sound waves to break up calcium in blood vessels can help patients with blocked arteries have safer and more successful heart valve procedures compared to the traditional balloon method.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rede Optimus Hospitalar SA (network)
• Locations: 5 sites (Ancona and 4 other locations)
• Trial ID: NCT05873842 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with symptomatic severe aortic stenosis and significant calcific PAD deemed arguable for the TF approach.

Not a fit: Patients with a life expectancy of less than one year or those with total occlusion of the aorta or major amputation planned will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to higher success rates and fewer complications for patients undergoing TAVI with calcified arteries.

How similar studies have performed: While the use of PTA has been explored, the application of IVL in this context is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Ancona and 4 other locations

• AOU Cardiology Ancona — Ancona, Italy (RECRUITING)
• AULLS3 Cardiology Mestre — Mestre, Italy (RECRUITING)
• AULSS2 Cardiology Treviso — Treviso, Italy (ACTIVE_NOT_RECRUITING)
• AOUI Cardiology Verona — Verona, Italy (RECRUITING)
• AULLS8 Cardiology Vicenza — Vicenza, Italy (RECRUITING)

Study contacts

• Study coordinator: Azinwi Phina Muna, phd

Conditions: Trans-femoral TAVI With Calcified Ilio-femoral Arteries, TAVI, Calcification, Ilio-femoral arteries