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Table 1 Summary of measurement items and point of data capture

From: Parent artery reconstruction for large or giant cerebral aneurysms using a Tubridge flow diverter (PARAT): study protocol for a multicenter, randomized, controlled clinical trial

Point of data capture

Pre-procedure

During procedure

Post-procedure

24 hours

Discharge

30 days

90 days

6 months

1 year

Window phase

    

±7 d

±15 d

±30 d

±30 d

Informed consent form

√

       

Inclusion/exclusion criteria

√

       

Withdrawal criteria

 

√

  

√

√

√

√

Medical history/demographic information

√

       

Physical examination (1)

√

  

√

  

√

 

Vital signs (2)

√

√

 

√

    

Routine urine and blood test

√

  

√

    

Blood biochemistry test (3)

√

  

√

    

Blood lipid test (4)

√

       

Pregnancy tests (5)

√

     

√

 

CTA, MRA or DSA

√

       

Clinical evaluation

 

√

  

√

√

√

√

DSA examination (6)

 

√

    

√

 

Adverse events

 

√

√

√

√

√

√

√

  1. 1. Physical examination: height, weight, and neurological presentation.
  2. 2. Vital signs: systolic pressure, diastolic pressure and heart rate.
  3. 3. Blood biochemistry tests: fasting blood glucose, blood urea nitrogen, TBIL, and serum creatine.
  4. 4. Blood lipid tests: total cholesterol, triglycerides, and low density lipoprotein.
  5. 5. Pregnancy tests: restricted to women with suspected pregnancy.
  6. 6. DSA examination: angiographic images will be sent to an independent laboratory for data analysis.