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RECRUITING
NCT05880641

Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access

Sponsor: EndoCore Lab s.r.l.

View on ClinicalTrials.gov

Summary

The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+/L6 Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices in iliac calcified access.

Official title: No-profit, Pilot, Observational, Multicentric, Prospective Study on the Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access to Facilitate Aortic Endovascular Repair. SHOCK-ACCESS STUDY.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2023-06-26

Completion Date

2027-09

Last Updated

2026-03-25

Healthy Volunteers

No

Locations (6)

Azienda Ospedaliero Universitaria delle Marche

Ancona, Ancona, Italy

Sant'Orsola Hospital

Bologna, Emilia-Romagna, Italy

Fondazione PTV - Policlinico Tor Vergata

Rome, Lazio, Italy

Ospedale San Giovanni di Dio

Florence, Tuscany, Italy

Ospedale Santa Maria della Misericordia di Perugia

Perugia, Umbria, Italy

Azienda Ospedaliero-Universitaria di Padova

Padova, Veneto, Italy