Study Protocol of a Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia.

Area of Science:

• Vascular Surgery
• Endovascular Interventions
• Clinical Research Methodology

Background:

• Acute lower limb ischemia (ALI) is a critical condition with evolving treatment options.
• Current guidelines for ALI lack high-level evidence and may not reflect current practice.
• There is a need for contemporary data on ALI etiology, treatment strategies, and patient outcomes.

Purpose of the Study:

• To provide insight into contemporary treatment strategies for ALI across Europe.
• To collect data on clinical results and prognosis for ALI patients.
• To establish a benchmark for future randomized controlled trials in ALI.

Main Methods:

• Prospective, international, multicenter, observational study (PROMOTE-ALI).
• Inclusion of patients with ALI (Rutherford classification grade I-III).
• Primary endpoint: 30-day amputation-free survival (AFS). Secondary endpoints include limb salvage and reintervention rates.

Main Results:

• This section details the study protocol and rationale, not preliminary results.
• The study aims to collect data on amputation-free survival, limb salvage, and reintervention rates.
• Data on complications and clinical outcomes of the index leg will also be gathered.

Conclusions:

• ALI presents a complex clinical challenge requiring updated evidence.
• The PROMOTE-ALI study is expected to yield crucial contemporary data on ALI management.
• Findings will inform future research, including randomized controlled trials, and improve clinical practice.