An observational study in Peripheral Arterial Disease and Critical Limb-Threatening Ischaemia, sponsored by EndoCore Lab s.r.l.. Terminated 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 the safety and efficacy of Peripheral Intravascular Lithotripsy system with Shockwave S4 catheter® for the treatment of de novo, re-stenosis or re-occlusive,calcified chronic total occlusion (CTOs) lesions in patients with Critical Limb Threatening Ischemia (CLTI).
The present study is designed as a multicentre, prospective, single-arm, observational study.
All eligible subjects for undergoing intervention with Shockwave S4 catheter® Peripheral Intravascular Lithotripsy (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 S4 catheter® Peripheral Intravascular Lithotripsy (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).
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 9 is below the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease 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 affected by lower extremities artery disease and referred for the endovascular treatment of infrapopliteal calcified stenoses and/or occlusions in patients with critical limb ischaemia
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 drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Composite of Acute Gain Index and freedom from clinically driven target lesion revascularization (CD-TLR) through 6 months post procedure
Acute Gain Index defined as the Acute Gain (difference between the vessel diameter before and after IVL) divided by the Reference Vessel Diameter CD-TLR defined as as repeat percutaneous intervention or surgical bypass graft to treat an angiographic significant restenosis (\>50%) at the level of the treated lesion ±10 mm (proximally and/or distally) in the presence of at least 1 of the following criteria: * recurrence of pain in the foot at rest that increases in the supine position * recurrence of pedal ulceration, evidence of halted healing * appearance of a new foot lesion * target vessel occlusion (by either angiography or DUS).
Time frame: 30 days, 6 months
Composite of Freedom from device and procedure-related death and freedom from target limb major amputation and clinically-driven and mechanical target lesion revascularization (CD-MTLR)
Composite of Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven and mechanical target lesion revascularization (CD-MTLR) through 6 months post-procedure
Time frame: 30 days, 6 months
Late Lumen Loss Index
Late Lumen Loss defined as Late Lumen Loss divided by Acute Lumen Gain
Time frame: 6 months
Rutherford class shift
Assess clinical improvement based on Rutherford class changes at 1, 6, 12 months, compared to baseline
Time frame: Baseline, 30 days, 6 months, 12 months
Amputation rate
defined as rate of minor and major amputations
Time frame: 30 days, 6 months, 12 months
CD-TLR
Clinically-driven target lesion revascularization (CD-TLR) is defined as any reintervention within the target lesion due to symptoms
Time frame: 30 days, 6 months
Technical success
Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the Shockwave S4 catheter, without a device malfunction after wire passage through the lesion.
Time frame: Day 1
Clinical Success
Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedures (as determined by the angiographic core lab)
Time frame: Day 1
Procedural Success
Procedural success defined as lesion success without the occurrence of major adverse events during the procedure
Time frame: Day 1
Ankle-brachial index (ABI) or trans-cutaneous oximetry (TcPO2) improvements
Assess ABI or TcPO2 improvements
Time frame: Baseline,30 days, 6 months, 12 months
Major adverse event (MAE) rates
Major adverse event (MAE) rates, defined as the first occurrence of any of the following: death from any cause, major amputation (above-the-ankle) of the target limb and target lesion revascularization (TLR), through 12 months
Time frame: 30 days, 6 months, 12 months
This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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EndoCore Lab s.r.l.