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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.
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Trials

ISSN: 1745-6215