| Methods |
R = sealed envelopes
Duplex and clinical FU unknown for blinding
Crossovers: none
Exclusions during trial: none
Patients lost to FU: unknown |
| Participants |
Israel
404 patients
422 operations
65.6% male
Mean age: 69.5 years
53.7% asymptomatic carotid disease
Comparability: sex, vascular risk factors, % asymptomatic disease similar in each group |
| Interventions |
Rx: polyester urethane patch angioplasty
Control: primary closure
Indication shunt for change in neurological status during carotid clamping or in patients in general anesthesia with stump pressure < 40 mmHg
Peri and postoperative aspirin: unknown |
| Outcomes |
Death < 30 days and end of FU
Stroke < 30 days and end of FU
Coronary event
Wound haemorrhage, infection, cranial nerve palsy
Restenosis > 50% or occlusion at end of FU (Duplex) |
| Notes |
Ex: small ICA or need for interposition graft
FU: 5 years |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
C ‐ Inadequate |
