Table 3

Unruptured aneurysms imaging follow up (per-protocol analysis).

All imaging at 6 months (range 3–9 months)	I	II	IIIa	IIIb	Total
Modified Raymond Roy	78	22	6	4	110	N/A
	I	II	III
Raymond Roy	78	22	10		110	N/A
	Yes		No
Adequate occlusion or not	100		10		110	N/A

All imaging at 18 months (range 12–30 months)	I	II	IIIa	IIIb	Total
Modified Raymond Roy	10	2	1	0	13	N/A
	I	II	III
Raymond Roy	10	2	1		13	N/A
	Yes		No
Adequate occlusion or not	12		1		13	N/A

*Two readings, one core laboratory and other by a local reader, were compared. For all discrepant readings, the core laboratory assessment was used. The data show that estimates of occlusion rates were accurate when performed locally for MRA and DSA.
†Interreader reliability used weighted (or unweighted for 2×2) Cohen’s kappa. N/A: not applicable for ‘All imaging’ as data contain some DSA and MRA cases for same patient.
‡On account of two discrepancies of IIIa (local reader) and II (core laboratory), statistically a chance finding. Clearly, more granular scores are statistically more informative.
§Includes one PEDV re-treatment patient. Patient had a previously-ruptured ICA PCOM aneurysm which was treated with coiling. Due to MRRC II remnant, patient subsequently re-treated with PEDV (and included in current study). After PEDV deployment (with some foreshortening included as an adverse event in table 2), short-term imaging follow up with MRA showed MRRC II remnant which persisted at medium-term imaging follow up with DSA. Patient underwent a second retreatment with a Flow-Redirection Endoluminal Device (FRED; MicroVention, Aliso Viejo, CA, USA).
CTA, computed tomography angiography; DSA, digital subtraction angiography; ICA, internal carotid artery; MRA, magnetic resonance angiography; MRRC, Modified Raymond Roy Classification; N/A, not applicable; OKM, O’Kelly Marotta grading; PCOM, posterior communicating artery ; PEDV, Pipeline Vantage Embolization Device.