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Table 1 Schedule of enrollment, interventions and assessments for the CoBaGI trial according to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) [24]

From: Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial

  Study period
Enrollment Allocation Post allocation Close-out
Time point −t1 0 t1 t2 t3 t4 tx
Enrollment:        
Eligibility screen X       
Informed consent X       
Allocation   X      
Interventions:        
Intervention CS    X     
Intervention BMS    X     
Assessments:
 CTA X    X X X  
 EQ-5D-5 L X    X X X  
 SF-36 X    X X X  
 Cost-effectiveness X    X X X  
 SAE     X X X X
 Mortality     X X X X
  1. −t1 = screening and enrollment, t1 = endovascular-stent placement, t2 = 6 months, t3 = 12 months, t4 = 24 months after intervention, tx = end of follow-up at 24 months
  2. BMS bare-metal stent, CS covered stent, CTA computed tomography angiography, SAE serious adverse event, SF-36 36-item Short Form Health Survey
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ISSN: 1745-6215