Shockwave ®S4 Catheter IVL to Treat Infrapopliteal Calcified Stenoses and/or Occlusions in CLTI P⦠(NCT05755412) | Clinical Trial Compass
TerminatedNot Applicable
Shockwave ®S4 Catheter IVL to Treat Infrapopliteal Calcified Stenoses and/or Occlusions in CLTI Patients (LEGACY)
Stopped: Low Enrollment rate: The study targeted a highly selected and complex patient population, making the identification and enrollment of eligible patients particularly challenging for all participating centers
Italy9 participantsStarted 2023-03-14
Plain-language summary
The study will evaluate the safety and efficacy of Peripheral Intravascular Lithotripsy system with Shockwave S4 catheterĀ® 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ā„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 ā„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 ocā¦
What they're measuring
1
Composite of Acute Gain Index and freedom from clinically driven target lesion revascularization (CD-TLR) through 6 months post procedure