Inyección de donaperminógeno selteoplasmido para isquemia crítica de miembro

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Incidence of benign and malignant tumors

Incidence of significant vision loss, blindness, or other obvious visual abnormalities

Incidence of major cardiovascular and cerebrovascular events

Pregnancy status and its outcomes

Amputation-free survival of the trial limb

Amputation-free survival or target vessel revascularization composite endpoint

Amputation-free survival or target vessel revascularization or neovascularization therapies (including stem cell or gene therapy) composite endpoint

Time to amputation of the trial limb

Level of amputation of the trial limb (above the knee, knee-ankle amputation, below the ankle amputation/toe amputation)

All-cause mortality rate, time to death

Major amputation rate of the trial limb (amputation plane above the ankle)

Minor amputation rate of the trial limb (below the ankle, including toe amputation)

Incidence of target vessel revascularization of the trial limb

Rehospitalization rate for worsening ischemic symptoms of the trial limb

Incidence of death due to acute myocardial infarction or stroke

Change in Rutherford classification of the trial limb compared to baseline at first dose

Change in rest pain of the trial limb assessed by Numeric Rating Scale (NRS) compared to baseline at first dose

Change in ulceration/necrosis of the trial limb compared to baseline at first dose