🏛️ Verified NIH Record • Updated 2026-07-29

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study (NCT06149650)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Cardiovascular and Interventional Radiological Society of Europe

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Krankenhaus der Barmherzigen Brüder — Eisenstadt

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (39 Sites)

Showing the first 25 of 39 sites.

  • Krankenhaus der Barmherzigen Brüder — Eisenstadt,
  • Medizinische Universität Graz — Graz,
  • Krankenhaus Barmherzige Brüder Linz — Linz,
  • Klinik Hietzing — Vienna,
  • Klinik Florisdorf — Vienna,
  • Hôpital Sacré Coeur de Montréal — Montreal,
  • CHU François Mitterrand — Dijon,
  • Institute Mutualiste Montsouris — Paris,
  • Rhéna Clinique de Strasbourg — Strasbourg,
  • Universitätsklinikum Köln — Cologne,
  • Universitätsmedizin Essen — Essen,
  • KRH Klinikum Robert Koch Gehrden — Hanover,
  • SLK-Heilbronn — Heilbronn,
  • Städtisches Klinikum — Karlsruhe,
  • Evangelisches Krankenhaus — Mülheim,
  • Friedrich Ebert Krankenhaus — Neumünster,
  • Schön Klinik Rendsburg — Rendsburg,
  • St Marien-Krankenhaus — Siegen,
  • Universitätsklinikum Tübingen — Tübingen,
  • Semmelweis University — Budapest,
  • Hospital General Universitario Dr. Balmis — Alicante,
  • Hospital General de Granollers — Granollers,
  • University of Navarra — Pamplona,
  • Ente Ospedaliero Cantonale — Lugano,
  • Kantonsspital Winterthur — Winterthur,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗