Grimm 2001.

Methods	Study design: RCT Method of randomisation: Concealed randomisation using randomisation envelopes. Blinding: Unblinded, intention‐to‐treat. Exclusions post‐randomisation: None. Losses to follow‐up: 12. Cross‐over to stenting in PTA group: none.
Participants	Country: Germany. Setting: Hospital. No. of participants: 53 (53 limbs). Age (mean): 69 years. Gender: 32 men, 21 women. Inclusion criteria: SFA lesion at least 1 cm from SFA origin (including proximal popliteal artery); stenosis no longer than 5 cm; target lesion diameter at least 70% by visual estimate; vessel diameter between 4 mm and 8 mm. Exclusion criteria: Lesions > 5 cm in length requiring more than 2 stents; multifocal disease or complete obstruction in the SFA; haemodynamically relevant stenoses in the lower limb previously untreated; occlusion of more than 2 runoff vessels; thrombus within the SFA; existing contraindications for vascular surgery or anticoagulation.
Interventions	PTA (23): over the wire. Stent (30): Stainless steel 'Palmaz'. 1000 mg aspirin bolus and 5000 iu heparin intraoperative. IV heparin for 24 hours, 100 mg aspirin lifelong.
Outcomes	3, 6, 12 and 24 month follow‐up: ABI, treadmill test, duplex ultrasound. 6‐month angiography. Primary patency defined as vessels without 1.5 greater systolic flow than in normal parts of the artery or angiographic reocclusion.
Notes	Participants with ipsilateral iliac or distal popliteal stenosis underwent angioplasty and were not excluded. No clear mention of distal vessel patency. Primary patency definition for angiography unclear. Aspirin compliance not assessed. Sponsor: Johnson & Johnson Interventional Systems.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation envelopes.
Allocation concealment (selection bias)	Low risk	Adequate concealed randomisation using 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	Medication not assessed. Participants with ipsilateral iliac or distal popliteal stenosis underwent angioplasty and were not excluded.