NCT05873842 TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
| NCT ID | NCT05873842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rede Optimus Hospitalar SA |
| Condition | Trans-femoral TAVI With Calcified Ilio-femoral Arteries |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-07-22 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-07-22 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Flavio Ribichini, MD, PhD
STUDY DIRECTOR
AOUI, Verona
Frequently Asked Questions
Who can join the NCT05873842 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trans-femoral TAVI With Calcified Ilio-femoral Arteries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05873842 currently recruiting?
Yes, NCT05873842 is actively recruiting participants. Contact the research team at trafic@redeoptimus.com for enrollment information.
Where is the NCT05873842 trial being conducted?
This trial is being conducted at Ancona, Italy, Mestre, Italy, Treviso, Italy, Verona, Italy and 1 additional location.
Who is sponsoring the NCT05873842 clinical trial?
NCT05873842 is sponsored by Rede Optimus Hospitalar SA. The principal investigator is Flavio Ribichini, MD, PhD at AOUI, Verona. The trial plans to enroll 50 participants.