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

Sponsor

EndoCore Lab s.r.l. (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05755412

Collaborator

Fondazione Italiana Vascolare (Other)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Critical Limb-Threatening Ischaemia

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

32 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
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
Late Lumen Loss Index [6 months]
Late Lumen Loss defined as Late Lumen Loss divided by Acute Lumen Gain
Rutherford class shift [Baseline, 30 days, 6 months, 12 months]
Assess clinical improvement based on Rutherford class changes at 1, 6, 12 months, compared to baseline
Amputation rate [30 days, 6 months, 12 months]
defined as rate of minor and major amputations
CD-TLR [30 days, 6 months]
Clinically-driven target lesion revascularization (CD-TLR) is defined as any reintervention within the target lesion due to symptoms
Technical success [Day 1]
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.
Clinical Success [Day 1]
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)
Procedural Success [Day 1]
Procedural success defined as lesion success without the occurrence of major adverse events during the procedure
Ankle-brachial index (ABI) or trans-cutaneous oximetry (TcPO2) improvements [Baseline,30 days, 6 months, 12 months]
Assess ABI or TcPO2 improvements
Major adverse event (MAE) rates [30 days, 6 months, 12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	I.R.C.C.S. MultiMedica	Sesto San Giovanni	Milano	Italy	20099
2	Casa di Cura Abano Terme	Abano Terme	Padova	Italy	35031
3	Ospedale Pederzoli	Peschiera Del Garda	Veneto	Italy	37019
4	Arcispedale Santa Maria Nuova	Reggio Emilia		Italy	42123