Neurosurgery notes/Literature/Vascular papers/Clip vs. Coil/CLARYS

CLARYS

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Clip vs. Coil

General

  • CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS) study

Class of Evidence

  • The post-market, open-label, non-randomised, prospective, multicentre study conducted in Europe.
  • It features a single-arm design.
  • The study included an independent assessment of safety outcomes and imaging.

Randomisation

  • Non-randomised trial.

Number of Patients

  • The study enrolled 60 patients with 60 ruptured bifurcation aneurysms.
  • At 1 year, 52 patients had clinical follow-up, and 46 patients (76.7%) had available or evaluable imaging for assessment by the independent core laboratory.

Length of Follow-up (1 year)

  • The primary endpoint of the CLARYS study was the assessment of the rebleeding rate at 1 month post-procedure.
  • Secondary endpoints evaluated the safety and effectiveness of the WEB device up to 12 months.
  • The present analyses specifically focus on safety and anatomical results at 1 year.

Number of Centres Involved with the Study

  • Patients were enrolled from 13 German and French centres.

Outcome

  • Primary Outcome (Rebleeding Protection): The study previously showed that the use of the WEB device provided effective protection against rebleeding with a good safety profile, including a zero rebleeding rate and a low complication rate at 1-month follow-up.
  • Angiographic Occlusion at 1 Year (for 46 evaluated aneurysms):
    • Complete occlusion (Raymond–Roy grade I) was achieved in 41.3% (19/46) of aneurysms.
    • Residual neck (Raymond–Roy grade II) was observed in 45.7% (21/46) of aneurysms.
    • Residual aneurysm filling (Raymond–Roy grade III) was present in 13.0% (6/46) of aneurysms.
    • Adequate occlusion (Raymond–Roy grades I and II) was reported in 87.0% (40/46) of aneurysms. This is considered a significant outcome given the complex anatomy of the treated aneurysms, with 60.0% having a wide neck and 88.3% having a dome to neck ratio <2.
    • No statistically significant differences in anatomical results were observed based on aneurysm location, neck size, or width.
  • Safety Profile:
    • Overall mortality at 1 month was 1.7% and at 1 year was 3.8%.
    • Overall morbidity at 1 month was 15.0% and at 1 year was 9.6%.
    • WEB-related 1-month and 1-year morbidity and mortality was 0%.
  • Retreatment: Six patients underwent target aneurysm retreatment during the 12-month study period. These retreatments were performed using modalities such as coiling, stent + coils, or flow diverters.

Critique of the Study

  • Limitations:
    • The study is limited by its single-arm design.
    • It has a small sample size of 60 patients.
    • There is an absence of long-term follow-up beyond 12 months.
  • Strengths and Contributions:
    • The study provides controlled and independent evaluation of 1-year angiographic follow-up for wide-neck ruptured aneurysms treated in multiple centres in Europe.
    • The results confirm the good outcome of occlusion when treating difficult-to-treat aneurysms in emergency situations.
    • The angiographic occlusion rates at 1 year are comparable to those already seen in previous multicentre studies that primarily included unruptured aneurysms.
    • While the complete occlusion rate (41.3%) was slightly lower than other WEB studies (51.7–54%), the adequate occlusion rate (87%) was slightly higher compared to other WEB series (79.3–85.4%), especially significant because the CLARYS population consisted entirely of ruptured aneurysms, which presents a higher clinical challenge.
    • The complete occlusion rate observed in CLARYS (41.3%) is higher than that reported in coil treatment studies for ruptured aneurysms (e.g., 33.2–34.4% in CLARITY).