Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Study Overview
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Brief Summary
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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.

Official Title
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Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Conditions
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Chronic Limb-Threatening Ischemia

Intervention / Treatment
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* Device: Shockwave Medical IVL System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Full cohort<br>Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care | Device: Shockwave Medical IVL System<br>* Comprehensive system consisting of generator, a connector cable and a single-use sterile catheter with integrated balloon for intravascular lithotripsy of peripheral artery calcification.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing and freedom from amputation | 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening) | 24 months | 
| Freedom from amputation | 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). | 24 months | 
| Amputation-free survival | 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) | through study completion, approximately 2 years | 
| Change in Rutherford classification category | Seven classification categories, from 0 (asymptomatic) to 6 (Major tissue loss) | 12 and 24 months | 
| Change in foot ischemia | Change in ankle-brachial index or toe pressure, depending on which data is available | 12 and 24 months | 
| Change in WIfi score | Three-digit score for comprehensive assessment of wound, ischemia and foot infection | 12 and 24 months | 
| Freedom from clinically-driven target lesion revascularization (CD-TLR) | 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. | 12 and 24 months | 
| CD-TLR-free survival | time between IVL treatment and any endovascular re-intervention to the target lesion (± 10 mm) | through study completion, approximately 2 years | 
| Primary patency rate | freedom from total occlusion without any endovascular or surgical re-intervention to the target lesion (± 10 mm) | 12 and 24 months | 
| Assisted primary patency rate | freedom from total occlusion following additional endovascular or surgical intervention(s) due to restenosis of the target lesion | 12 and 24 months | 
| Secondary patency rate | freedom from total occlusion following additional endovascular or surgical intervention(s) due to occlusion of the target lesion | 12 and 24 months | 
| Technical success of IVL | residual diameter stenosis ≤30% after IVL and before any potential adjunctive intervention | on the day of the procedure | 
| Overall procedural success | residual stenosis ≤30% by the end of the complete procedure | on the day of the procedure | 
| Frequency and severity of procedural complications and other adverse events | Grading according to the classification system of the Cardiovascular and Interventional Radiological Society of Europe (PMID: 28584945) | Within 30 days after the procedure | 
| Patient-reported health-related quality-of-life | EuroQol questionnaire EQ-5D-5L | at 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLTI