Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Wound healing

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

Time frame: 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).

Time frame: 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)

Time frame: through study completion, approximately 2 years

Change in Rutherford classification category

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

Time frame: 12 and 24 months

Change in foot ischemia

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

Time frame: 12 and 24 months

Change in WIfi score

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

Time frame: 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.

Time frame: 12 and 24 months

CD-TLR-free survival

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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 12 and 24 months

Technical success of IVL

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

Time frame: on the day of the procedure

Overall procedural success

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

Time frame: 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

Time frame: Within 30 days after the procedure

Patient-reported health-related quality-of-life

EuroQol questionnaire EQ-5D-5L

Time frame: at 6, 12 and 24 months