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

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Casa di Cura Abano Terme
RECRUITING
Abano Terme
Ospedale Pederzoli
RECRUITING
Peschiera Del Garda
Arcispedale Santa Maria Nuova
SUSPENDED
Reggio Emilia
I.R.C.C.S. MultiMedica
SUSPENDED
Sesto San Giovanni
Contact Information
Primary
Gabriele Morselli, PharmD
gabriele.morselli@endocorelab.org
+39 3499105666
Backup
Mariano L Palena, MD
marianopalena@hotmail.com
+39 3498924343
Time Frame
Start Date: 2023-03-14
Estimated Completion Date: 2025-03
Participants
Target number of participants: 32
Sponsors
Collaborators: Fondazione Italiana Vascolare
Leads: EndoCore Lab s.r.l.

This content was sourced from clinicaltrials.gov

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