Lepantalo 2009.

Methods	Study design: randomised controlled multicenter study, no statement of blinding Method of randomisation: closed envelopes Power calculation performed: no Losses to follow up: 13 participants Intention‐to‐treat analysis: yes
Participants	Country: Finland Setting: 15 vascular centres in Scandinavia Number of participants: 44 Age: mean age in the endovascular group 64 years (range 48 to 79), mean age in the bypass group 66 years (range 53 to 80) Sex: male and female Inclusion criteria: SFA occlusion ranging from 5 to 25 cm in length, adjacent inflow and outflow segments close to normal, vessel diameter between 4.8 and 6.5 mm, at least one patent distal run off vessel, at least 1 cm of healthy SFA below and above the lesion Exclusion criteria: allergy or contraindications to contrast medium, adjuvant antithrombotic medication or bleeding diathesis, presence of one or several previously placed endografts or stents in the SFA segment, other planned endovascular therapy of the same segment, evolving malignancy and any other illness posing an immediate threat to life, life‐expectancy less than 2 years, noncompliance, participation in another vascular clinical study less than 30 days prior to inclusion
Interventions	Treatment: femoro‐popliteal bypass, preferably with a 6 mm non‐coated expanded PTFE graft, with inflow from the common femoral artery to the popliteal artery above the knee Control: Viabahn endograft in the SFA Duration: the study was terminated when recruiting had continued for 42 months and one year follow‐up data were available for 28 participants
Outcomes	Primary outcomes: primary patency Secondary outcomes: functional success, complications, costs
Notes	No source of funding/sponsorship was reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The randomisation was stratified by the centre and by the severity of ischaemia". Comment: Unclear whether an appropriate method of randomisation was used.
Allocation concealment (selection bias)	Unclear risk	Quote: "Randomisation was made using closed envelopes". Comment: It remains unclear whether envelopes were sequentially numbered.
Blinding (performance bias and detection bias) All outcomes	Low risk	See below.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The study report did not state blinding. Both participants and personnel were probably not blinded. However, the lack of blinding was not likely to influence the outcome and the outcome measures.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quotes: “Completion angiogram was mandatory to reveal possible technical errors and for verification of the morphological result in both groups” and “Patency had to be demonstrated by duplex ultrasound or other imaging modalities at every control visit”. Comment: Blinding of outcome assessment not stated, but most probably no blinding existed. The assessment of the main outcomes is by imaging and is therefore unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient information to permit judgment.
Selective reporting (reporting bias)	High risk	Costs were prespecified as a secondary outcome parameter, but no outcomes reported.
Other bias	High risk	Terminated prematurely because of recruitment issues and lack of benefit of endoluminal stent‐graft placement in the SFA over bypass surgery. Did not provide specific reintervention criteria to maintain primary patency and is, therefore, subject to reintervention bias.