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

NCT05880641 | Recruiting

• 1 other identifier: IVL 022022
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Aortic Diseases; Aorto-Iliac Atherosclerosis; Peripheral Arterial Disease

Keywords

Aortic Disease; Intravascular Lithotripsy; Hostile Access

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Technical success of Shockwave™ M5+ IVL

  Day 1

• Composite of Freedom from iliac complications

  Day 1, 1 Month

• Freedom from vessel flow-limiting dissections

  Day 1, 1 Month

• Freedom from vessel distal embolization

  Day 1, 1 Month

• Freedom from vessel trauma

  Day 1, 1 Month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EndoCore Lab s.r.l.: lead
• Fondazione Italiana Vascolare: collaborator

Study Sites (6)

Azienda Ospedaliero Universitaria delle Marche

Ancona, Ancona, 60126, Italy

RECRUITING

Sant'Orsola Hospital

Bologna, Emilia-Romagna, 40138, Italy

NOT YET RECRUITING

Fondazione PTV - Policlinico Tor Vergata

Rome, Lazio, 00133, Italy

RECRUITING

Ospedale San Giovanni di Dio

Florence, Tuscany, 50143, Italy

NOT YET RECRUITING

Ospedale Santa Maria della Misericordia di Perugia

Perugia, Umbria, 06156, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria di Padova

Padua, Veneto, 35128, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Study Officials

• Stefano Fazzini, MD

  Fondazione PTV - Policlinico Tor Vergata

  PRINCIPAL INVESTIGATOR

• Pierluigi Antignani, MD

  Fondazione Italiana Vascolare (FIV)

  STUDY CHAIR

• Gabriele Morselli, PharmD

  EndoCore Lab

  STUDY DIRECTOR

Central Study Contacts

Daniela Ramaccini, PhD, PharmD

CONTACT

+39 3534390426; d.ramaccini@endocorelab.org

Stefano Fazzini, MD

CONTACT

+39 06 20902 833; stefano.fazzini@uniroma2.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 30, 2023
• Study Start: June 26, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

IT (6)