Skip to main content

Table 1 Visits and exams Patients should be followed at regular intervals during one year after the initial percutaneous deep vein arterialization procedure in accordance with standard of care and local practice. Visits and exams scheduled for this post-market study are presented in 1 below (keys: ■ mandatory, □ optional)

From: PROMISE international; a clinical post marketing trial investigating the percutaneous deep vein arterialization (LimFlow) in the treatment of no-option chronic limb ischemia patient

Exams Baseline Treatment Week 02 Month 01 Month 02 Month 03 Month 06 Month 09 Month 12
Eligibility         
Demographics         
Infection statusa         
Venous mappingb         
Angiogram        
Ultrasound   Duplex   Duplex Duplex Duplex Duplex Duplex Duplex
Medication
Creatinine       
Rutherford   
WIfI   
Wound pictures  
Pain  
Perfusion  
Quality of Life     
Adverse events  
  1. aWound culture and/or blood analysis (WBC, CRP, ESR)
  2. bPhlebography, duplex ultrasound, MRV or CTV, depending on what is available