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

NCT05755412 | Terminated

• 1 other identifier: IVL012022
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Peripheral Arterial Disease; Critical Limb-Threatening Ischaemia

Keywords

PAD; CLTI

Outcome Measures

Primary Outcomes (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).

  30 days, 6 months

Secondary Outcomes (10)

• 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)

  30 days, 6 months

• Late Lumen Loss Index

  6 months

• Rutherford class shift

  Baseline, 30 days, 6 months, 12 months

• Amputation rate

  30 days, 6 months, 12 months

• CD-TLR

  30 days, 6 months

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 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (6)

I.R.C.C.S. MultiMedica

Sesto San Giovanni, Milano, 20099, Italy

Location

Casa di Cura Abano Terme

Abano Terme, Padova, 35031, Italy

Location

Ospedale Pederzoli

Peschiera del Garda, Veneto, 37019, Italy

Location

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

Bologna, 40138, Italy

Location

Ospedale "Morgagni di Forlì

Forlì, 47121, Italy

Location

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

Udine, 33100, Italy

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Mariano L Palena, MD

  Casa di Cura Abano Terme

  PRINCIPAL INVESTIGATOR

• Pierluigi Antignani, MD

  Fondazione Vascolare Italiana

  STUDY CHAIR

• Gabriele Morselli, PharmD

  EndoCoreLab s.r.l.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 6, 2023
• Study Start: March 14, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

IT (6)