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Table 4 Trial assessment requirements

From: IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial

 

Baseline

Procedure

Discharge

30 days (24-45)

3 months (84-105)(84-105)

6 months (174-195)

1 year (335-395)

2 years (700-790)

3 years (1065-1125)

4 years (1430-1490)

5 years (1795-1855)

Unsched

Demography

X

           

Medical History

Physical Exam

X

 

X

X

 

X

X

X

   

X

Concomitant Meds

Anticoagulant/antiplatelet therapy

X1

X2

X

X

        

Informed Consent

X

           

Incl/Excl Evaluation

X

X

          

Routine Lab testing (see Table 2)

X3

 

X

X

 

X

X

X

   

X

Ankle pressure, toe pressure, TcPO2, PVR (at least 1 required) and brachial pressure

X3

 

X

X

 

X

X

X

   

X

Wound assessment7 and Wound Care

X

 

X8

X

 

X

X

X

   

X

Rutherford Staging

X

  

X

 

X

X

X

   

X

EQ5D

X3

    

X

X

X

   

X

WIQ

     

X

X

X

   

X

Angiography

X3

X

    

X4

    

X5

Hospital FU Visits

   

X

 

X

X

X

    

Telephone FU

    

X

   

X

X

X

 

Adverse Event Assessment

 

X

X

X

X6

X

X

X

X6

X6

X6

X

  1. 1Aspirin (100 mg) at least 4 days prior to the index intervention, alternatively at least 500 mg loading dose prior to or within 2 hours post procedure; Clopidogrel 75 mg daily at least 4 days prior to the index intervention, alternatively at least 300 mg loading dose prior to or within 2 hours post procedure (or ticlopidine, if required); the use of bivalirudin (Angiox™) was allowed as an alternative to heparin.
  2. 2Following the PTA procedure, subjects were to be prescribed daily acetyl-salicylic acid (ASA) (100 mg) indefinitely and daily clopidogrel (75 mg) (or ticlopidine, if required) for at least 1 month following the procedure. Prolonged antiplatelet therapy could be given at the discretion of the physician and should be considered after placement of stents.
  3. 3Within 6 weeks of procedure.
  4. 4For Angio Sub-group subjects only.
  5. 5If subject undergoes an unscheduled angiogram; a copy of the angiogram must be forwarded to the Angiographic Core Lab for adjudication.
  6. 6Only death and amputations.
  7. 7Wound assessment performed via the SilhouetteMobile.
  8. 8Only Wound Care.