Vroegindeweij 1997.

Methods	Study design: single centre, randomised controlled trial with 2 parallel groups. Recruitment period two years. No power calculation
Participants	Country: the Netherlands Sample size 51: 36 males, 15 females=15 Mean age (range): experimental group 65 (46‐78) years, control group 64 (41‐82) years Inclusion criteria: intermittent claudication; above knee femoropopliteal stenosis or occlusions, maximal length of lesion 5cm; no previous interventions in ipsilateral femoropoliteal segment. Exclusion criteria: multisegmental disease, poor run off, unable to comply with follow‐up protocol .
Interventions	Experimental group: primary stenting using a balloon expanded Palmaz stent, n=24. Control: balloon angioplasty, n=27.
Outcomes	Primary outcome: restenosis or reocclusion Secondary outcome Clinical: ABI, technical failure, embolic episodes, clinical deterioration and thrombosis.
Notes	Only experimental group offered post‐interventional anticoagulant heparin pharmacotherapy. All patients started on oral coumadin after the procedure for the first three months, thereafter the treatment was changed to aspirin 80 mg/d indefinitely.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Described as randomised; numbered envelopes opened sequentially.
Allocation concealment?	Unclear risk	Not clear if opaque envelopes.
Blinding? All outcomes	High risk	Neither the surgical or radiological staff were blinded and it remains unclear whether the subjects were themselves blinded.
Incomplete outcome data addressed? All outcomes	Low risk	"intention to treat".. "patients with crossover treatments remained assigned to the treatment group of randomization".
Free of selective reporting?	Low risk	All measures of technical and clinical success reported.
Free of other bias?	Low risk	No significant difference between groups of baseline risk factors or clinical status.

ABPI = ankle brachial pressure index 
 g = gram 
 i.v. = intravenous