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Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Health checks and monitoring — no treatment given
Type of study: Observational (no treatment given)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Shockwave Medical IVL System (device)
How long the study runs: Study runs about 53 months (dates as stated)
About the drug or intervention: Shockwave Medical IVL System — device: Comprehensive system consisting of generator, a connector cable and a single-use sterile catheter with integrated balloon for intravascular lithotripsy of peripheral artery calcification.
Patient visit burden: Not specified by the sponsor

Type of study: Observing health over time
Ages: 18 Years and over
Who: All
Number of participants: 400
Started: 2024-07-15
Last checked: 2026-07

Plain English Summary

What is this study?

• Testing a new treatment for chronic limb-threatening ischemia
• Clinical study - 400 participants
• 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)

Who can take part?

• Ages 18 Years and over
• Diagnosed with chronic limb-threatening ischemia

Where?

• Bedford - Bedfordshire Hospitals NHS Foundation Trust
• Frimley - Frimley Health NHS Foundation Trust
• Hull - Hull University Teaching Hospitals NHS Trust
• Leeds - Leeds Teaching Hospitals NHS Trust
• +10 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Chronic Limb-Threatening Ischemia

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

What the study is looking for

✓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.

Who cannot take part

✗\< 18 years old;
✗Incapacity or refusal to give agreement to take part;
✗Ongoing pregnancy;
✗Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.

See the full criteria

Inclusion Criteria: * 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. Exclusion Criteria: * \< 18 years old; * Incapacity or refusal to give informed consent; * Ongoing pregnancy; * Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.