| Study characteristics |
| Methods |
Allocation concealment: sealed envelopes
Blinding of outcome assessment: duplex and clinical FU blinding unknown
Cross‐overs: none
Exclusions during trial: none
Participants lost to FU: unknown |
| Participants |
Country: Israel
Number of participants: 404
Number of operations: 422
Sex: 65.6% male
Mean age: 69.5 years
% asymptomatic carotid disease: 53.7%
% stenosis: unknown
Comparability: sex, vascular risk factors and % asymptomatic disease similar in each group |
| Interventions |
Treatment: polyester urethane patch angioplasty
Control: primary closure
Indication for shunt: change in neurological status during carotid clamping or in participants in general anaesthesia with stump pressure < 40 mmHg
Medication: unknown |
| Outcomes |
Death within 30 days and during FU; stroke within 30 days and during FU; coronary event; wound haemorrhage, infection or cranial nerve palsy; restenosis > 50% or occlusion at end of FU (duplex) |
| Notes |
Exclusion criteria: small ICA diameter or need for interposition graft
FU: 5 years
Funding sources: none reported |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Random sequence generation not reported. |
| Allocation concealment (selection bias) |
Low risk |
Sealed envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Blinding of study participants not reported. Because of the nature of the intervention (patch or primary closure), the surgeon could not be blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Blinding of outcome assessment not reported. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Number of participants lost to follow‐up not reported. |
| Selective reporting (reporting bias) |
Unclear risk |
Unclear whether study authors reported the results of all prestated outcomes. |
| Other bias |
Low risk |
None suspected. |
