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Use of Shockwave M5+ IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access — SHOCK-ACCESS  

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

This study is designed as no-profit, pilot, observational, multicentric, prospective study. All eligible subjects for undergoing intervention with Shockwave™ M5+ Peripheral Intravascular Lithotripsy Catheter (IVL) at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating. Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data. Once patients are enrolled, their demographics, medical history, disease-relevant conditions, treatment details and outcomes will be collected for up to 12 months from the procedure. The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done. The procedure with Shockwave™ M5+ Peripheral Intravascular Lithotripsy Catheter (IVL) will be performed as per the current instructions for use. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days),12 months (±30 days). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05880641
Study type Observational
Source EndoCore Lab s.r.l.
Contact Gabriele Morselli, PharmD
Phone +39 3499105666
Email g.morselli@endocorelab.org
Status Recruiting
Phase
Start date June 26, 2023
Completion date June 2025
View Details
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