Peripheral Arterial Disease Clinical Trial
— LEGACYOfficial 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
NCT number | NCT05755412 |
Other study ID # | IVL012022 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 14, 2023 |
Est. completion date | March 2025 |
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).
Status | Recruiting |
Enrollment | 32 |
Est. completion date | March 2025 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Casa di Cura Abano Terme | Abano Terme | Padova |
Italy | Ospedale Pederzoli | Peschiera Del Garda | Veneto |
Italy | Arcispedale Santa Maria Nuova | Reggio Emilia | |
Italy | I.R.C.C.S. MultiMedica | Sesto San Giovanni | Milano |
Lead Sponsor | Collaborator |
---|---|
EndoCore Lab s.r.l. | Fondazione Italiana Vascolare |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 30 days, 6 months | |
Secondary | Late Lumen Loss Index | Late Lumen Loss defined as Late Lumen Loss divided by Acute Lumen Gain | 6 months | |
Secondary | Rutherford class shift | Assess clinical improvement based on Rutherford class changes at 1, 6, 12 months, compared to baseline | Baseline, 30 days, 6 months, 12 months | |
Secondary | Amputation rate | defined as rate of minor and major amputations | 30 days, 6 months, 12 months | |
Secondary | CD-TLR | Clinically-driven target lesion revascularization (CD-TLR) is defined as any reintervention within the target lesion due to symptoms | 30 days, 6 months | |
Secondary | 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. | Day 1 | |
Secondary | 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) | Day 1 | |
Secondary | Procedural Success | Procedural success defined as lesion success without the occurrence of major adverse events during the procedure | Day 1 | |
Secondary | Ankle-brachial index (ABI) or trans-cutaneous oximetry (TcPO2) improvements | Assess ABI or TcPO2 improvements | Baseline,30 days, 6 months, 12 months | |
Secondary | 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 |
30 days, 6 months, 12 months |
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