Assessment schedule
Timeline items | Enrolment and treatment | Follow-up | |||||
Window period | Preoperative screening: 15–0 day | During operation 0 day | Within 7 days postsurgery or before discharge | 1 month ±7 days postsurgery | 6 months ±30 days postsurgery | 12 months ±30 days postsurgery | 24 months ±30 days postsurgery |
Informed consent†† | ● | ||||||
Medical history/demographic data | ● | ||||||
Vital signs | ● | ||||||
Blood routine test* | ● | ● | |||||
Blood biochemistry† | ● | ● | |||||
Routine coagulation test ‡ | ● | ||||||
Pregnancy test § | ● | ||||||
Imaging examination ¶ | DSA/CTA/MRA | DSA/CTA | CTA | ||||
mRS score | ● | ● | ● | ● | ● | ||
Inclusion/exclusion criteria | ● | ● | |||||
Surgical treatment with instruments | ● | ||||||
Device defects | ● | ||||||
Combined medication records** | ● | ● | ● | ● | ● | ● | ● |
Adverse events | ● | ● | ● | ● | ● | ● |
*Blood routine includes: white blood cell count, red blood cell count, platelet count and haemoglobin.
†Blood biochemistry includes: total bilirubin, direct bilirubin, alanine aminotransferase, aspartate aminotransferase, creatinine and glucose.
‡Routine coagulation test: thrombin time, prothrombin time, activated partial thromboplastin time, international normalised ratio.
§Pregnancy tests are performed only when necessary.
¶If a subject cannot undergo DSA examination at 6 months postoperatively due to specific reasons, CTA examination may be accepted for efficacy evaluation at 6 months postoperatively; if a subject fails to return to the hospital for follow-up at 6 months or 12 months postoperatively due to specific reasons, imaging follow-up at another hospital may be accepted.
**Combined medication records only include anti-platelet agents, anti-coagulants and statins.
††The laboratory test results and scoring results within 14 days prior to signing the informed consent form are considered valid. Similarly, CTA, MRA or DSA results within 45 days prior to signing the informed consent form are also considered valid.
CTA, CT angiography; DSA, digital subtraction angiography; MRA, MR angiography; mRS, Modified Rankin Scale.