Table 2.

Primary and secondary outcome measures in CALCIO

	Outcome measure	When	Reported by
Effectiveness—Primary	Composite of wound healing and freedom from amputation	12 months	Investigator
Effectiveness—Secondary	Technical success of IVL (diameter stenosis ≤ 30% after IVL)	Treatment day	BCIR
	Overall procedural success (diameter stenosis ≤ 30% after complete treatment in case of adjunctive interventions)	Treatment day	BCIR
	Wound healing	12 and 24 months	Investigator
	Freedom from amputation	12 and 24 months	Investigator
	Amputation-free survival	Time-to-event	Investigator
	Change in Rutherford category	12 and 24 months	Investigator
	Change in limb perfusion (based on ankle–brachial index, ankle systolic pressure, toe pressure, or transcutaneous oximetry)	12 and 24 months	Investigator
	Change in WIfI score	12 and 24 months	Investigator
	CD-TLR	12 and 24 months	Investigator
	CD-TLR-free survival	Time-to-event	Investigator
	Patency (primary, assisted primary, secondary)	12 and 24 months	Investigator
Safety	Incidence and severity of procedural complications and major AEs	Within 30 days after IVL	Investigator
HRQoL	EuroQol EQ-5D-5L questionnaire	6, 12, and 24 months	Patient
Exploratory	Change in vascular calcification	Treatment day	BCIR

IVL, intravascular lithotripsy; WIfI score, wound; infection, and foot infection score; CD-TLR, clinically driven target lesion revascularization; AEs, adverse events; HRQoL, health-related quality of life; BCIR, blinded central image review