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Aortic DiseasesSHOCK-ACCESSNCT05880641

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

An observational study of Aortic Diseases and Aorto-Iliac Atherosclerosis, run by EndoCore Lab s.r.l. at 6 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
40 participants
Where
6 sitesItaly
Study dates
26 Jun 2023to Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Daniela Ramaccini, PhD, PharmD contact

+39 3534390426

d.ramaccini@endocorelab.org

Stefano Fazzini, MD contact

+39 06 20902 833

stefano.fazzini@uniroma2.it

6 sites in 1 country

Italy6 sites, 6 recruiting

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, Ancona, 60126

    Emanuele Gatta, MD, emanuele.gatta@ospedaliriuniti.marche.it

    Recruiting

  • Sant'Orsola Hospital

    Bologna, Emilia-Romagna, 40138

    Mauro Gargiulo, Prof., +39 051 344025, mauro.gargiulo2@unibo.it

    Not yet recruiting

  • Ospedale San Giovanni di Dio

    Florence, Tuscany, 50143

    Stefano Michelagnoli, MD, +39 055 6932675, stefano.michelagnoli@asf.toscana.it

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria di Padova

    Padova, Veneto, 35128

    Franco Grego, Prof., +39 049 8212636, franco.grego@unipd.it

    Not yet recruiting

  • Ospedale Santa Maria della Misericordia di Perugia

    Perugia, Umbria, 06156

    Massimo Lenti, MD, +39 0755786436, massimo.lenti@gmail.com

    Not yet recruiting

  • Fondazione PTV - Policlinico Tor Vergata

    Rome, Lazio, 00133

    Stefano Fazzini, MD, +39 06 20902 833, stefano.fazzini@uniroma2.it

    Recruiting

Other trials in Italy

About this study

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.

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.

Read the 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).

Keywords
Aortic Disease, Intravascular Lithotripsy, Hostile Access
Medical subject headings
Aortic Diseases, Peripheral Arterial Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minimum Lumen Diameter (MLD) Gain

    Minimum Lumen Diameter (MLD) Gain defined as the difference between MLD post-procedure and MLD pre-procedure.

    Measured: Baseline, Day 1

Secondary outcomes (19)

  1. Technical success of Shockwave™ M5+ IVL

    Technical success of Shockwave™ M5+ IVL defined as the successful delivery and positioning of the aortic endograft;

    Measured: Day 1

  2. Composite of Freedom from iliac complications

    Freedom from iliac complications composite (flow-limiting dissections, distal embolizations, trauma, rupture) at day 1, 30 days

    Measured: Day 1, 1 Month

  3. Freedom from vessel flow-limiting dissections

    Freedom from vessel flow-limiting dissections at day 1 and 1 Month

    Measured: Day 1, 1 Month

  4. Freedom from vessel distal embolization

    Freedom from vessel distal embolization at day 1 and 1 Month

    Measured: Day 1, 1 Month

  5. Freedom from vessel trauma

    Freedom from vessel trauma at day 1 and 1 Month

    Measured: Day 1, 1 Month

  6. Freedom from vessel rupture

    Freedom from vessel rupture at day 1 and 1 Month

    Measured: Day 1, 1 Month

  7. Freedom from bailout manoeuvres

    Freedom from bailout manoeuvres (stenting/endoconduits) at day 1

    Measured: Day 1

  8. Freedom from iliac secondary procedures

    Freedom from iliac secondary procedures other than IVL at day 1

    Measured: Day 1

  9. Freedom from access-site adjunctive/secondary procedures;

    Freedom from access-site adjunctive/secondary procedures

    Measured: Day 1

  10. 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

    Measured: 1 month, 6 months, 12 months

  11. Freedom from SAE

    Freedom from SAE at discharge/30 days

    Measured: Day 1, 1 month

  12. All-cause mortality

    All-cause mortality at 1, 6 and 12 months;

    Measured: 1 month, 6 months, 12 moths

  13. 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

    Measured: 1 month, 6 months, 12 months

  14. Rutherford shift

    Rutherford shift from procedure at 30 days, 6 and 12 months (for AIOD subgroup)

    Measured: 1 month, 6 months, 12 months

  15. 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;

    Measured: Day 1

  16. 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;

    Measured: Day 1

  17. Clinical Success

    Clinical Success, defined as procedural success without SAE before discharge

    Measured: Day 1, 1 month

  18. Freedom from procedure related complications

    Freedom from procedure related complications

    Measured: Day 1

  19. 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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start26 Jun 2023
  3. Primary completionAug 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05880641
Sponsor's protocol ID
IVL 022022
Acronym
SHOCK-ACCESS
Status last verified
Mar 2026
First submitted
19 May 2023
Last updated
25 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Diseases and Aorto-Iliac Atherosclerosis, run by EndoCore Lab s.r.l. at 6 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniela Ramaccini, PhD, PharmD (+39 3534390426, d.ramaccini@endocorelab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimum Lumen Diameter (MLD) Gain (time frame: Baseline, Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05880641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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