Cardiovascular and Interventional Radiological Society of Europe
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.
Chronic Limb-Threatening Ischemia
Shockwave Medical IVL System
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 400 participants |
| Official Title : | Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study |
| Actual Study Start Date : | 2024-07-15 |
| Estimated Primary Completion Date : | 2028-07-15 |
| Estimated Study Completion Date : | 2028-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
ST Marien Hospital
Win, Germany, 57072
RECRUITING
University Hospital Tübingen
Tübingen, Germany, 72076
RECRUITING
Royal Free London NHS Foundation Trust
London, United Kingdom, Drainage
RECRUITING
St George's University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0qt
RECRUITING
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY