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NCT Number: NCT06149650

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

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.

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Key information

Conditions

Chronic Limb-Threatening Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Krankenhaus der Barmherzigen Brüder, Eisenstadt, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Wound healing and freedom from amputation

    Time frame: 12 months

    Composite of wound healing defined as the healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening) and freedom from amputation defined as the absence of any amputation of the treated limb: minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure).

Secondary outcomes

  1. Wound healing

    Time frame: 24 months

    Healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening)

  2. Freedom from amputation

    Time frame: 24 months

    Absence of any amputation of the treated limb: minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure).

  3. Amputation-free survival

    Time frame: through study completion, approximately 2 years

    time between IVL treatment and amputation of the target limb, minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure)

  4. Change in Rutherford classification category

    Time frame: 12 and 24 months

    Seven classification categories, from 0 (asymptomatic) to 6 (Major tissue loss)

  5. Change in foot ischemia

    Time frame: 12 and 24 months

    Change in ankle-brachial index or toe pressure, depending on which data is available

  6. Change in WIfi score

    Time frame: 12 and 24 months

    Three-digit score for comprehensive assessment of wound, ischemia and foot infection

  7. Freedom from clinically-driven target lesion revascularization (CD-TLR)

    Time frame: 12 and 24 months

    freedom from any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion.

  8. CD-TLR-free survival

    Time frame: through study completion, approximately 2 years

    time between IVL treatment and any endovascular re-intervention to the target lesion (± 10 mm)

  9. Primary patency rate

    Time frame: 12 and 24 months

    freedom from total occlusion without any endovascular or surgical re-intervention to the target lesion (± 10 mm)

  10. Assisted primary patency rate

    Time frame: 12 and 24 months

    freedom from total occlusion following additional endovascular or surgical intervention(s) due to restenosis of the target lesion

  11. Secondary patency rate

    Time frame: 12 and 24 months

    freedom from total occlusion following additional endovascular or surgical intervention(s) due to occlusion of the target lesion

  12. Technical success of IVL

    Time frame: on the day of the procedure

    residual diameter stenosis ≤30% after IVL and before any potential adjunctive intervention

  13. Overall procedural success

    Time frame: on the day of the procedure

    residual stenosis ≤30% by the end of the complete procedure

  14. Frequency and severity of procedural complications and other adverse events

    Time frame: Within 30 days after the procedure

    Grading according to the classification system of the Cardiovascular and Interventional Radiological Society of Europe

  15. Patient-reported health-related quality-of-life

    Time frame: at 6, 12 and 24 months

    EuroQol questionnaire EQ-5D-5L

Sponsors and collaborators

Lead sponsor

Cardiovascular and Interventional Radiological Society of Europe

Other

Collaborators

  • Shockwave Medical, Inc.

Registry information

Acronym: CALCIO

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 29, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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