An observational study in Aortic Diseases, Aorto-Iliac Atherosclerosis and Peripheral Arterial Disease, sponsored by EndoCore Lab s.r.l.. Recruiting at 6 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by EndoCore Lab s.r.l. · Observational
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.
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).
108 studies on the registry are indexed under Aortic Diseases; 43 are open to participants now.
This study's planned enrollment of 40 is below the median of 186 across 62 observational studies indexed under Aortic Diseases.
Browse Aortic Diseases studies →EndoCore Lab s.r.l. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Minimum Lumen Diameter (MLD) Gain
Minimum Lumen Diameter (MLD) Gain defined as the difference between MLD post-procedure and MLD pre-procedure.
Time frame: Baseline, Day 1
Technical success of Shockwave™ M5+ IVL
Technical success of Shockwave™ M5+ IVL defined as the successful delivery and positioning of the aortic endograft;
Time frame: 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
Time frame: Day 1, 1 Month
Freedom from vessel flow-limiting dissections
Freedom from vessel flow-limiting dissections at day 1 and 1 Month
Time frame: Day 1, 1 Month
Freedom from vessel distal embolization
Freedom from vessel distal embolization at day 1 and 1 Month
Time frame: Day 1, 1 Month
Freedom from vessel trauma
Freedom from vessel trauma at day 1 and 1 Month
Time frame: Day 1, 1 Month
Freedom from vessel rupture
Freedom from vessel rupture at day 1 and 1 Month
Time frame: Day 1, 1 Month
Freedom from bailout manoeuvres
Freedom from bailout manoeuvres (stenting/endoconduits) at day 1
Time frame: Day 1
Freedom from iliac secondary procedures
Freedom from iliac secondary procedures other than IVL at day 1
Time frame: Day 1
Freedom from access-site adjunctive/secondary procedures;
Freedom from access-site adjunctive/secondary procedures
Time frame: 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
Time frame: 1 month, 6 months, 12 months
Freedom from SAE
Freedom from SAE at discharge/30 days
Time frame: Day 1, 1 month
All-cause mortality
All-cause mortality at 1, 6 and 12 months;
Time frame: 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
Time frame: 1 month, 6 months, 12 months
Rutherford shift
Rutherford shift from procedure at 30 days, 6 and 12 months (for AIOD subgroup)
Time frame: 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;
Time frame: 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;
Time frame: Day 1
Clinical Success
Clinical Success, defined as procedural success without SAE before discharge
Time frame: Day 1, 1 month
Freedom from procedure related complications
Freedom from procedure related complications
Time frame: 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
Time frame: Baseline
Started Jun 2023 (actual). Primary completion is estimated for Aug 2027, 50 months after the start.
Of 33 observational studies under Aortic Diseases, half reached primary completion within 98 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 203. This study's planned 50 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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