Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
St Marien-Krankenhaus
RECRUITING
Siegen
Universitätsklinikum Tübingen
RECRUITING
Tübingen
United Kingdom
Imperial College Healthcare NHS Trust
RECRUITING
London
Royal Free London NHS Foundation Trust
RECRUITING
London
St George's University Hospitals NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Claire Poulet, Dr
calcio@cirse.org
+431904200371
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 400
Treatments
Full cohort
Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care
Related Therapeutic Areas
Sponsors
Leads: Cardiovascular and Interventional Radiological Society of Europe
Collaborators: Shockwave Medical, Inc.

This content was sourced from clinicaltrials.gov