Critical Limb Ischemia (CLI) narrowed arteries Vascular disease
Conditions
Interventions
IVUS-guided endovascular intervention of BTK arteries.
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age >18 years old; * CLTI, defined as the presence of PAD in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration; * Indication for BTK endovascular revascularization, as set by the multidisciplinary team; * De novo vascular target lesion; * Written informed consent.
Exclusion criteria
Exclusion criteria: * Target lesions with a length of 20 cm; * Kawarada Type III pedal arch (no patent dorsalis pedis artery, no patent plantar artery); * Below-the-knee (BTK) critical limb ischemia (CLTI) based on acute thrombosis or thrombo-emboli; * Renal insufficiency with a glomerular filtration rate (GFR) of less than 15 ml/min but not on dialysis; * Contrast allergy; * Non-salvageable limbs due to extensive tissue necrosis or infection (Rutherford classification of chronic limb ischemia 6 or WiFi classification wound score 3); * ASA-classification of IV or higher; * Ejection fraction 2; * Target lesions not amenable for endovascular treatment by operators* decision after baseline angiography (Angio-1); * Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is NLG following IVUS-guided intervention when compared with angiography-guided intervention after six weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include ALG and per-procedural complications such as arterial dissections. | — |
Countries
Netherlands
Contacts
Public ContactO Aouam
St. Antonius Ziekenhuis
Outcome results
None listed