TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
AOU Cardiology Ancona
RECRUITING
Ancona
AULLS3 Cardiology Mestre
RECRUITING
Mestre
AULSS2 Cardiology Treviso
ACTIVE_NOT_RECRUITING
Treviso
AOUI Cardiology Verona
RECRUITING
Verona
AULLS8 Cardiology Vicenza
RECRUITING
Vicenza
Contact Information
Primary
Azinwi Phina Muna, phd
trafic@redeoptimus.com
+49 157 80 58 5869
Backup
Cristian Di Biase, Phd
Cristian.dibiase@redeoptimus.com
+49 176 89982768
Time Frame
Start Date: 2024-07-22
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 50
Treatments
PTA-assisted group
IVL-assisted group
Sponsors
Leads: Rede Optimus Hospitalar SA

This content was sourced from clinicaltrials.gov