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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Aortic Diseases; Aorto-Iliac Atherosclerosis

Detailed Description

This study is designed as no-profit, pilot, observational, multicentric, prospective study.

All eligible subjects for undergoing intervention with Shockwave™ M5+/L6 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+/L6 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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Stefano Fazzini, MD; Phone Number: +39 06 20902 833; Email: stefano.fazzini@uniroma2.it
• Study Contact Backup: Name: Daniela Ramaccini, PhD, PharmD; Phone Number: +39 3534390426; Email: d.ramaccini@endocorelab.org

Study Locations

• Italy
  • Ancona
    • Ancona, Ancona, Italy, 60126
      • Recruiting
      • Azienda Ospedaliero Universitaria delle Marche
      • Contact: Emanuele Gatta, MD; Email: emanuele.gatta@ospedaliriuniti.marche.it
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Not yet recruiting
      • Sant'Orsola Hospital
      • Contact: Mauro Gargiulo, Prof.; Phone Number: +39 051 344025; Email: mauro.gargiulo2@unibo.it
  • Lazio
    • Rome, Lazio, Italy, 00133
      • Recruiting
      • Fondazione PTV - Policlinico Tor Vergata
      • Contact: Stefano Fazzini, MD; Phone Number: +39 06 20902 833; Email: stefano.fazzini@uniroma2.it
  • Tuscany
    • Florence, Tuscany, Italy, 50143
      • Not yet recruiting
      • Ospedale San Giovanni di Dio
      • Contact: Stefano Michelagnoli, MD; Phone Number: +39 055 6932675; Email: stefano.michelagnoli@asf.toscana.it
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • Not yet recruiting
      • Ospedale Santa Maria della Misericordia di Perugia
      • Contact: Massimo Lenti, MD; Phone Number: +39 0755786436; Email: massimo.lenti@gmail.com
  • Veneto
    • Padua, Veneto, Italy, 35128
      • Not yet recruiting
      • Azienda Ospedaliero-Universitaria di Padova
      • Contact: Franco Grego, Prof.; Phone Number: +39 049 8212636; Email: franco.grego@unipd.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with aortic diseases (abdominal, thoracic or thoraco-abdominal, aneurysms, dissections, PAU, IMH) with hostile iliac access (calcified and narrowed) associated or not to aorto-iliac occlusive disease (AIOD).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimum Lumen Diameter (MLD) Gain	Minimum Lumen Diameter (MLD) Gain defined as the difference between MLD post-procedure and MLD pre-procedure.	Baseline, Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success of Shockwave™ M5+ IVL	Technical success of Shockwave™ M5+ IVL defined as the successful delivery and positioning of the aortic endograft;	Day 1
Composite of Freedom from iliac complications	Freedom from iliac complications composite (flow-limiting dissections, distal embolizations, trauma, rupture) at day 1, 30 days	Day 1, 1 Month
Freedom from vessel flow-limiting dissections	Freedom from vessel flow-limiting dissections at day 1 and 1 Month	Day 1, 1 Month
Freedom from vessel distal embolization	Freedom from vessel distal embolization at day 1 and 1 Month	Day 1, 1 Month
Freedom from vessel trauma	Freedom from vessel trauma at day 1 and 1 Month	Day 1, 1 Month
Freedom from vessel rupture	Freedom from vessel rupture at day 1 and 1 Month	Day 1, 1 Month
Freedom from bailout manoeuvres	Freedom from bailout manoeuvres (stenting/endoconduits) at day 1	Day 1
Freedom from iliac secondary procedures	Freedom from iliac secondary procedures other than IVL at day 1	Day 1
Freedom from access-site adjunctive/secondary procedures;	Freedom from access-site adjunctive/secondary procedures	Day 1
Primary patency of the target lesion for each iliac axis treated with IVL	Primary patency of the target lesion for each iliac axis treated with IVL: defined as a lesion without a severe restenosis/occlusion and without target lesion reintervention (TLR) within 1, 6 and 12 month	1 month, 6 months, 12 months
Freedom from SAE	Freedom from SAE at discharge/30 days	Day 1, 1 month
All-cause mortality	All-cause mortality at 1, 6 and 12 months;	1 month, 6 months, 12 moths
Freedom from Clinically-driven TLR	Freedom from Clinically-driven TLR at 30 days, 6 and 12 months (any TLR for symptoms or ABI decrease > 30%; Clinically-driven Target Lesion Revascularization (CD-TLR) defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure	1 month, 6 months, 12 months
Rutherford shift	Rutherford shift from procedure at 30 days, 6 and 12 months (for AIOD subgroup)	1 month, 6 months, 12 months
Device Success	Device Success, defined as correct placement of the catheter and delivery of IVL (inflating balloon-delivering sonic pressure waves-deflating balloon) and recovery of the undamaged catheter;	Day 1
Procedural Success	Procedural Success, defined as the presence of a residual stenosis < 50% (without stents and/or iliac limbs) or ≤ 30% (with stents and/or iliac limbs) by completion angiogram estimation;	Day 1
Clinical Success	Clinical Success, defined as procedural success without SAE before discharge	Day 1, 1 month
Freedom from procedure related complications	Freedom from procedure related complications	Day 1
CASS score (exploratory endpoint)	Calcified Access Severity Score (CASS) at baseline CASS (Calcified Access Severity Score) multifactorial severity scale, which can be referred to for the definition of iliac access hostility	Baseline

Collaborators and Investigators

• Sponsor: EndoCore Lab s.r.l.
• Collaborators: Fondazione Italiana Vascolare
• Investigators: Principal Investigator: Stefano Fazzini, MD, Fondazione PTV - Policlinico Tor Vergata; Study Chair: Pierluigi Antignani, MD, Fondazione Italiana Vascolare (FIV); Study Director: Gabriele Morselli, PharmD, EndoCore Lab

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Intravascular Lithotripsy; Aortic Disease; Hostile Access
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Aortic Diseases
• Other Study ID Numbers: IVL 022022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No