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Peripheral Arterial DiseaseLEGACYNCT05755412

Shockwave ®S4 Catheter IVL to Treat Infrapopliteal Calcified Stenoses and/or Occlusions in CLTI Patients (LEGACY)

An observational study of Peripheral Arterial Disease and Critical Limb-Threatening Ischaemia, run by EndoCore Lab s.r.l. at 6 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
9 participants
Where
6 sitesItaly
Study dates
14 Mar 2023to 30 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

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 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

Who may be able to join

  • Age ≥18 years
  • Patient has signed an approved informed consent form
  • Patient with Critical Limb Ischaemia, Rutherford category 4 (ischaemic rest pain), 5(minor tissue loss) or 6 (major tissue loss)
  • Patient with Stenotic (>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery
  • The vascular lesion length will be no longer than 150 mm.
  • Patient with no significant disease at the inflow: common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to enrollment, and patient with no significant disease at the outflow - runoff to ankle level: plantar for posterior tibial, pedal for anterior tibial, anterior and posterior perforant branches for peroneal vessels or previous successful revascularization of the disease segments (inflow-outflow)
  • Live expectancy > 1 year.
  • Presence at least ≥1 filling pedal vessel on the target limb.

Who cannot join

  • Subject pregnant or planning to become pregnant during the study
  • Subject no able to perform the follow up or other factors making clinical follow-up difficult
  • Acute or Subacute limb ischaemia which requires thrombolysis as first treatment modality or previous thrombolytic therapy in the last 48-72 hours.
  • Known allergy to concomitant medication, antiplatelet anti-coagulant or thrombolytic medication
  • Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteries
  • Significant stenoses (> 50%) distal to the target lesion that might require revascularization or impede run-off
  • Desert foot condition. No Patent foot main arteries
  • Subject enrolled in another investigational study that has not reached its primary endpoint

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Italy6 sites

  • Casa di Cura Abano Terme

    Abano Terme, Padova, 35031

  • IRCCS - Azienda Ospedaliera-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, 40138

  • Ospedale "Morgagni di Forlì

    Forlì, 47121

  • Ospedale Pederzoli

    Peschiera del Garda, Veneto, 37019

  • I.R.C.C.S. MultiMedica

    Sesto San Giovanni, Milano, 20099

  • Azienda Sanitaria Universitaria ed Integrata Santa Maria della Misericordia Udine (ASU FC)

    Udine, 33100

Other trials in Italy

About this study

Official title: Observational, Prospective, Single-arm Multicentric Study of Shockwave ®S4 Catheter IVL (Intravascular Lithotripsy) Balloon for the Treatment of Infrapopliteal Calcified Stenoses and/or Occlusions in Patients With Critical Limb Ischaemia

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).

Read the detailed description

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).

Keywords
PAD, CLTI
Medical subject headings
Peripheral Arterial Disease

What is being measured

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

  1. 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).

    Measured: 30 days, 6 months

Secondary outcomes (10)

  1. 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

    Measured: 30 days, 6 months

  2. Late Lumen Loss Index

    Late Lumen Loss defined as Late Lumen Loss divided by Acute Lumen Gain

    Measured: 6 months

  3. Rutherford class shift

    Assess clinical improvement based on Rutherford class changes at 1, 6, 12 months, compared to baseline

    Measured: Baseline, 30 days, 6 months, 12 months

  4. Amputation rate

    defined as rate of minor and major amputations

    Measured: 30 days, 6 months, 12 months

  5. CD-TLR

    Clinically-driven target lesion revascularization (CD-TLR) is defined as any reintervention within the target lesion due to symptoms

    Measured: 30 days, 6 months

  6. 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.

    Measured: Day 1

  7. 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)

    Measured: Day 1

  8. Procedural Success

    Procedural success defined as lesion success without the occurrence of major adverse events during the procedure

    Measured: Day 1

  9. Ankle-brachial index (ABI) or trans-cutaneous oximetry (TcPO2) improvements

    Assess ABI or TcPO2 improvements

    Measured: Baseline,30 days, 6 months, 12 months

  10. 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

    Measured: 30 days, 6 months, 12 months

Timeline

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

  1. First posted6 Mar 2023
  2. Study start14 Mar 2023
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2025

Why it stopped: Low Enrollment rate: The study targeted a highly selected and complex patient population, making the identification and enrollment of eligible patients particularly challenging for all participating centers

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
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05755412
Sponsor's protocol ID
IVL012022
Acronym
LEGACY
Status last verified
Mar 2026
First submitted
22 Feb 2023
Last updated
25 Mar 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease and Critical Limb-Threatening Ischaemia, 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 8 inclusion and 8 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: stopped early, 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?

The study was stopped early (reason given: Low Enrollment rate: The study targeted a highly selected and complex patient population, making the identification and enrollment of eligible patients particularly challenging for all participating centers). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Acute Gain Index and freedom from clinically driven target lesion revascularization (CD-TLR) through 6 months post procedure (time frame: 30 days, 6 months). 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 NCT05755412.

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.

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