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

NCT ID: NCT05880641

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2025-06-30

Brief 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.

Detailed 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).

Conditions

Aortic Diseases; Aorto-Iliac Atherosclerosis; Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years old;
• Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study;
• Patient presenting with aortic disease indicated for endovascular treatment considered unfeasible based on severely calcified iliac access and outer diameter of the "ideal" aortic endograft at onset of the procedure (considering the main body and/or contralateral limb in case of iliac distal landing zone);
• Patients presenting a ratio > 0.2 between outer diameter of the aortic stent graft delivery system (OD-SG) and minimum lumen diameter (MLD); decision concerning SG will be taken balancing the lower profile on the market and the better graft fit for patient's anatomy;
• Patients presenting calcium grade 3 or 4 accordingly to 360° coronary classification (grade 1 = 0-90°, grade 2 = 90°-180°; grade 3 = 180°-270°; grade 4 = 270°-360°);
• Patients presenting a lesion length > 20 mm, intended as the sum of all calcified iliac lesions between two endpoints, from the aortic bifurcation up to the proximal common femoral artery (CFA);
• Patients eligible for treatment with Shockwave M5+ IVL device;
• Patients presenting with aortic disease indicated for endovascular treatment associated or not to aorto-iliac occlusive disease (Rutherford classification score II - VI for chronic limb ischemia);
• Patients compliant with the conduct of follow-up visits according to the timelines specified in the protocol.

Exclusion Criteria

• Bilateral Iliac Occlusion;
• Urgent setting with presence of iliac thrombus (acute limb ischemia);
• Any patient considered to be hemodynamically unstable at procedure onset;
• Patients refusing treatment;
• Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated;
• Patients with a history of prior life-threatening contrast medium reaction;
• Life expectancy of less than twelve months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Italiana Vascolare

OTHER

Sponsor Role: collaborator

EndoCore Lab s.r.l.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefano Fazzini, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione PTV - Policlinico Tor Vergata

Pierluigi Antignani, MD

Role: STUDY_CHAIR

Fondazione Italiana Vascolare (FIV)

Gabriele Morselli, PharmD

Role: STUDY_DIRECTOR

EndoCore Lab

Locations

Sant'Orsola Hospital

Bologna, Emilia-Romagna, Italy

Site Status: NOT_YET_RECRUITING

Fondazione PTV - Policlinico Tor Vergata

Rome, Lazio, Italy

Site Status: RECRUITING

Ospedale San Giovanni di Dio

Florence, Tuscany, Italy

Site Status: NOT_YET_RECRUITING

Ospedale Santa Maria della Misericordia di Perugia

Perugia, Umbria, Italy

Site Status: NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria di Padova

Padua, Veneto, Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Gabriele Morselli, PharmD

Role: CONTACT

g.morselli@endocorelab.org

+39 3499105666

Stefano Fazzini, MD

Role: CONTACT

stefano.fazzini@uniroma2.it

+39 06 20902 833

Facility Contacts

Mauro Gargiulo, Prof.

Role: primary

mauro.gargiulo2@unibo.it

+39 051 344025

Stefano Fazzini, MD

Role: primary

stefano.fazzini@uniroma2.it

+39 06 20902 833

Stefano Michelagnoli, MD

Role: primary

stefano.michelagnoli@asf.toscana.it

+39 055 6932675

Massimo Lenti, MD

Role: primary

massimo.lenti@gmail.com

+39 0755786436

Franco Grego, Prof.

Role: primary

franco.grego@unipd.it

+39 049 8212636

Other Identifiers

IVL 022022

Identifier Type: -

Identifier Source: org_study_id