Trials / Recruiting
RecruitingNCT06149650
Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Shockwave Medical IVL System | Comprehensive system consisting of generator, a connector cable and a single-use sterile catheter with integrated balloon for intravascular lithotripsy of peripheral artery calcification. |
Timeline
- Start date
- 2024-07-15
- Primary completion
- 2028-07-15
- Completion
- 2028-12-31
- First posted
- 2023-11-29
- Last updated
- 2025-12-30
Locations
39 sites across 8 countries: Austria, Canada, France, Germany, Hungary, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT06149650. Inclusion in this directory is not an endorsement.