TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Launched by REDE OPTIMUS HOSPITALAR SA · May 15, 2023

Keywords

ClinConnect Summary

This clinical trial, known as TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI, is looking to compare two different methods for helping patients with a heart condition called severe aortic stenosis. This condition makes it hard for the heart to pump blood effectively. The trial will evaluate whether a new treatment using a special tool called intravascular lithotripsy (IVL), which helps break up calcium build-up in blood vessels, is more effective and safe compared to the traditional method using just a balloon to open the arteries. This study is specifically for patients who have calcified ilio-femoral arteries and are planning to undergo a procedure called transcatheter aortic valve implantation (TAVI).

To participate in this trial, you need to be at least 18 years old, have severe aortic stenosis, and be prepared to give written consent. Participants will go through a thorough evaluation, including a CT scan of the heart and blood vessels, to ensure they are suitable for the trial. If eligible, you can expect to receive either the new IVL treatment or the balloon treatment during your TAVI procedure. It’s important to know that this trial is not yet recruiting, so you would need to wait until it starts to participate.

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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