Skip to main content
. 2020 Sep 29;2020(9):CD006680. doi: 10.1002/14651858.CD006680.pub3

Nakamura 1995.

Study characteristics
Methods Randomisation method: random number table
Allocation: not stated
Intervention model: parallel
Blinding: none
Participants Country: United States of America
No. of participants: 39:
2.7 mm TEC atherectomy plus BA: 13
4.0 mm TEC atherectomy plus BA: 13
BA: 13
Age (mean (years) ± SD):
2.7 mm TEC: 64 ± 6
4.0 mm TEC: 70 ± 6
BA: 61 ± 4.1
Inclusion criteria: occluded SFA with 1 to 2 block claudication
Exclusion criteria: those with previous femoropopliteal graft or "insufficient run‐off vessels"
Interventions BA versus 2.7 mm TEC atherectomy plus BA versus 4.0 mm TEC atherectomy plus BA
Outcomes Initial and 6‐month vessel patency
Preprocedure and 6‐month ABI
Notes 6‐month ABI only reported for participants with primary patency at 6 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table used for randomisation.
Allocation concealment (selection bias) High risk Not specifically stated.
Blinding of participants and personnel (performance bias)
All outcomes High risk Neither participants nor personnel were blinded.
Blinding of outcome assessment (detection bias)
All outcomes High risk No mention of blinding of outcome assessment.
Incomplete outcome data (attrition bias)
All outcomes Low risk Complete data available to 6 months.
Selective reporting (reporting bias) Unclear risk Initial and 6 month patencies reported. ABI only reported for participants whose vessels remained patent at 6 months.
Other bias High risk No mention of antiplatelet protocol pre‐ or postprocedure.