RecruitingNot Applicable

TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Italy50 participantsStarted 2024-07-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age \> 18 years
. Written informed consent
. Diagnosis of symptomatic severe aortic stenosis
. Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion.
. High-quality Contrast-enhanced ECG gated computed tomography (CT) scan of the heart, aorta and low-limb arteries
. 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.
. Hostility score \>/= 23 in at least one segment of the axis under evaluation.

Exclusion criteria

. Life expectancy \< 1 year
. Subject has active infection requiring antibiotic therapy.
. STS score ≥8%
. Leriche syndrome or other forms of total occlusion of the aorta or both iliac axes.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility and safety on the trans-femoral (TF) approach

Timeframe: Index procedure - 1 Month

Trial details

NCT IDNCT05873842

SponsorRede Optimus Hospitalar SA

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2026-11-01

Contact for this trial

Azinwi Phina Muna, phd

+49 157 80 58 5869 trafic@redeoptimus.com

View on ClinicalTrials.gov More Trans-femoral TAVI With Calcified Ilio-femoral Arteries trials