Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06149650 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Study acronym: CALCIO
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Site details revised at 39 of 39 sites
    v7
  2. Publications: details revised at 1 of 2 entriesv6
  3. Study sites: 5 to 39
    • Secondary endpoints: details revised at 1 of 15 entries
    • Publications: 1 to 2
    v5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 5
    • Primary completion date: Jul 2028 to Jul 15, 2028
    • Study completion date: Jul 2028 to Dec 31, 2028
    • Start date changed from estimate of Jul 2024 to Jul 15, 2024
  5. Start date: Apr 2024 to Jul 2024
    • Primary and study completion dates: Apr 2028 to Jul 2028
    v3
  6. Secondary endpoints: 16 to 15v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06149650
Lead Sponsor Cardiovascular and Interventional Radiological Society of Europe
Collaborators: Shockwave Medical, Inc.
Conditions
(from sponsor)		 Chronic Limb-Threatening Ischemia
Related terms Chronic Limb-Threatening Ischemia
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov