Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-27 @ 2:01 PM
Study NCT ID:
NCT06149650
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2023-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study
Sponsor:
Cardiovascular and Interventional Radiological Society of Europe
Organization:
Study Overview
Official Title:
Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALCIO
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: