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Table 1 Schedule of enrollment and follow-up points

From: Excimer laser ablation combined with drug-coated balloon versus drug-coated balloon in the treatment of de novo atherosclerotic lesions in lower extremities (ELABORATE): study protocol for a real-world clinical trial

   

Follow-up visits

 

Long-term follow-up

Measuring

Outcome variables

Baseline

Intervention

1 month

3, 6, 12 months

(Every 12 months until 60 months)

Instrument

Allowed visit window

4 weeks to 1 week

 

 ± 5 days

 ± 10 days

 ± 30 days

 
 

Before intervention

     

Informed consent

X

     

Inclusion and exclusion criteria

X

     

Calcification class

 

X

   

PACSS

Target lesion length

 

X

    

Location of lesions

 

X

    

Runoff vessels

 

X

    

Minimal luminal diameter (a)

 

X

   

DSA

Reference vessel diameter (b)

 

X

   

DSA

Minimal luminal diameter (c)

 

X

   

IVUS

Reference vessel diameter (d)

 

X

   

IVUS

ABI

 

X

 

X

X

 

Rutherford class

 

X

 

X

X

 

Ulcer size

 

X

 

X

X

 

Pain

 

X

 

X

X

NRS

QoL

 

X

 

X

X

SF-36V2

Primary patency

   

X

X

DUS

All-cause mortality

  

X

   

Major amputation

   

X

X

 

Bailout stent

 

X

    

Distal embolization

 

X

    

Study completion/termination record

At study exit

     
  1. ABI ankle-brachial index, QoL quality of life, PACSS peripheral arterial calcium scoring system [25], DSA digital substract angiography, IVUS intravascular ultrasound, NRS numerical rating scale, DUS Doppler ultrasound
  2. (a) (b): evaluated by DSA in both groups before and after intervention; (c) (d): evaluated by IVUS in study group before and after laser
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BMC Cardiovascular Disorders

ISSN: 1471-2261

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