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).
Study Type
OBSERVATIONAL
Enrollment
32
I.R.C.C.S. MultiMedica
Sesto San Giovanni, Milano, Italy
SUSPENDEDCasa di Cura Abano Terme
Abano Terme, Padova, Italy
RECRUITINGOspedale Pederzoli
Peschiera del Garda, Veneto, Italy
RECRUITINGComposite 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
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Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
SUSPENDEDCD-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