Last reviewed · How we verify
NCT06149650: CALCIO
Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
trial testing Shockwave Medical IVL System in Chronic Limb-Threatening Ischemia in 400 participants. Currently enrolling.
15 July 2028
Quick facts
| Lead sponsor | Cardiovascular and Interventional Radiological Society of Europe |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 15 July 2024 |
| Primary completion | 15 July 2028 |
| Estimated completion | 31 December 2028 |
| Sites | 39 locations across France, Austria, United Kingdom, Germany, Hungary, Canada, Switzerland, Spain |
Drugs / interventions tested
- Shockwave Medical IVL System
Conditions studied
- Chronic Limb-Threatening Ischemia — all drugs for Chronic Limb-Threatening Ischemia →
Sponsor
Cardiovascular and Interventional Radiological Society of Europe
Who can join
18 and older, any sex, with Chronic Limb-Threatening Ischemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Intravascular Lithotripsy for Patients with Chronic Limb-Threatening Ischemia: Study Protocol for CALCIO, a Prospective Multicenter Observational Investigation.
Uberoi R, Reimer P, Chun JY, Goyault G, et al · · 2026 · PMID 41703104 · DOI 10.1007/s00270-025-04335-w
Verify or expand the search:
- PubMed search for NCT06149650
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Cardiovascular and Interventional Radiological Society of Europe trials
Trials by the same sponsor.
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- NCT03775980 — CIRSE Emprint Microwave Ablation Registry · completed
- NCT03086096 — CIRSE Registry for LifePearl Microspheres · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06149650 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cardiovascular and Interventional Radiological Society of Europe
- Last refreshed: 30 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06149650.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing