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Clinical Trial ● Currently Recruiting NCT06149650

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study — Recruiting • Cardiology / Cardiovascular • NCT06149650.

📅 13 May 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
NCT ID
NCT06149650
Sponsor
Cardiovascular and Interventional Radiological Society of Europe
Start
2024-07-15
ClinicaliQ Trial Snapshot
  • Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study — Recruiting • Cardiology / Cardiovascular • NCT06149650.
  • Intervention being tested: Real-world effectiveness and safety of intravascular lithotripsy (IVL) using the Shockwave system to treat calcified arterial lesions in the femoropopliteal and crural vessels in patients with chronic limb-threatening ischemia.
  • Patient eligibility overview: Adults with CLTI presenting with calcified lesions in the lower limb vasculature who are suitable candidates for percutaneous endovascular intervention with intravascular lithotripsy.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural lesions in patients with chronic limb-threatening ischemia (CLTI). The primary objective of CALCIO is to understand the effectiveness of IVL in promoting wound healing and preventing amputation. The secondary objectives of CALCIO are to evaluate the immediate effectiveness of the treatment in restoring vessel patency as well as its safety and impact on patients' quality of life.

Eligibility Snapshot
  • : * Patient with chronic limb-threatening ischemia (Rutherford Category ≥4) * Femoropopliteal and/or crural calcified lesions visible on fluoroscopy; * Treatment with IVl using the Shockwave Medical IVL System.

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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