Using Shockwave Catheter to Treat Blocked Arteries in Patients with Severe Limb Ischemia
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
EndoCore Lab s.r.l. · NCT05755412
This study is testing a new catheter treatment for patients with severe leg artery blockages to see if it helps improve their blood flow and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EndoCore Lab s.r.l. (other) |
| Locations | 4 sites (Sesto San Giovanni, Milano and 3 other locations) |
| Trial ID | NCT05755412 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and effectiveness of the Shockwave S4 catheter for treating calcified chronic total occlusions in patients suffering from Critical Limb Threatening Ischemia (CLTI). It is a multicenter, prospective, single-arm study where eligible patients will undergo the procedure and have their medical data collected for up to 12 months. The study focuses on patients with significant arterial blockages in the infrapopliteal region and aims to gather insights on treatment outcomes without additional testing. Follow-up visits will occur at 30 days, 6 months, and 12 months post-procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Critical Limb Ischemia and specific arterial blockages in the infrapopliteal region.
Not a fit: Patients with significant disease in the inflow or outflow arteries, or those with a life expectancy of less than one year, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve blood flow and reduce the risk of limb loss in patients with severe arterial blockages.
How similar studies have performed: Other studies using similar intravascular lithotripsy techniques have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sesto San Giovanni, Milano and 3 other locations
- I.R.C.C.S. MultiMedica — Sesto San Giovanni, Milano, Italy (SUSPENDED)
- Casa di Cura Abano Terme — Abano Terme, Padova, Italy (RECRUITING)
- Ospedale Pederzoli — Peschiera Del Garda, Veneto, Italy (RECRUITING)
- Arcispedale Santa Maria Nuova — Reggio Emilia, Italy (SUSPENDED)
Study contacts
- Principal investigator: Mariano L Palena, MD — Casa di Cura Abano Terme
- Study coordinator: Gabriele Morselli, PharmD
- Email: gabriele.morselli@endocorelab.org
- Phone: +39 3499105666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Arterial Disease, Critical Limb-Threatening Ischaemia, PAD, CLTI