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. 2014 Jun 24;2014(6):CD006767. doi: 10.1002/14651858.CD006767.pub3

Vroegindeweij 1997.

Methods Study design: RCT
Method of randomisation: Concealed randomisation using sealed randomisation envelopes.
Blinding: Unblinded, intention‐to‐treat.
Exclusions post‐randomisation: None.
Losses to follow‐up: None.
Cross‐over to stenting in PTA group: 4.
Participants Country: The Netherlands.
Setting: Hospital.
No. of participants: 51 (51 limbs).
Age (mean): 64.5 years.
Gender: 36 men, 15 women.
Inclusion criteria: Lesions confined to femoropopliteal artery.
Exclusion criteria: Below‐knee popliteal disease; multisegmental disease; disease > 5 cm in length.
Interventions PTA (27): over the wire.
Stent (24): stainless steel 'Palmaz'.
 5000 iu heparin intraoperative. 3 months warfarin.
Outcomes 6 weeks, 3, 6, 9, 12, 18 and 24 month follow‐up: ABI, treadmill test, duplex ultrasound.
Primary patency defined as proximal peak velocity ratio > 2.5 on duplex ultrasound.
Notes Runoff vessel patency at time of intervention unclear. Participants with coexisting ipsilateral proximal arterial stenosis included.
Sponsor: No statement.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Concealed randomisation using sealed randomisation envelopes.
Allocation concealment (selection bias) Low risk Concealed randomisation using sealed randomisation envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Impossible in this type of trial.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not stated but radiological investigations would show stent placement.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No statement on attrition.
Selective reporting (reporting bias) Low risk All outcomes accounted for.
Other bias Unclear risk Warfarin used initially then unclear medication protocol.