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PRET Patients P rone to R ecurrence after E ndovascular T reatment

PRET Patients P rone to R ecurrence after E ndovascular T reatment. XIX SYMPOSIUM NEURORADIOLOGICUM. Angiographic recurrences risk factors Size  10mm Recurrent aneurysm. Background and purpose.  50% of recurrence. These aneurysms are poorly represented in clinical trials

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PRET Patients P rone to R ecurrence after E ndovascular T reatment

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  1. PRET PatientsPronetoRecurrence afterEndovascularTreatment XIX SYMPOSIUM NEURORADIOLOGICUM

  2. Angiographic recurrences risk factors Size  10mm Recurrent aneurysm Background and purpose  50% of recurrence

  3. These aneurysms are poorly represented in clinical trials HELPS study included some large aneurysms (~25%) and no recurrent aneurysms Background and purpose

  4. New coils have been designed to preserve the safety while improving on long-term efficacy No scientific evidence Some concerns have been raised about the safety of hydrocoils in large aneurysms Background and purpose

  5. The use of hydrogel-coated coils in patients with large aneurysms or presenting major recurrences after a previous endovascular treatment decreases the recurrence rate from 50% to 32% at 18 months as compared to bare platinum coils Primary hypothesis

  6. The number of adverse events is similar in both groups. Morbidity and mortality related to treatment remains unchanged Secondary hypothesis

  7. Design Multicentre, randomized, controlled trial with concealed allocation Two cohorts, 250 subjects each, independently randomized PRET 1 : One ruptured or unruptured aneurysm, never treated, 10 mm or larger PRET 2 : A major (i.e. requiring retreatment) recurrence after previous coiling It is possible for a site to recruit selectively in either cohort, depending on site participation in other competing trials

  8. Design • Inclusion Criteria • PRET-1 or PRET-2 lesion • Anatomy of lesion is such that treatment is possible with either type of coil • Endovascular physician is indifferent to the use of either type of coil • Patient is 18 or older • Life expectancy is more than 2 years • Exclusion criteria • Other aneurysms requiring treatment during the same session • Associated cerebral AVMs • Parent vessel occlusion without simultaneous endosaccular coiling of the aneurysm is the primary intent of the procedure • Contraindication to endovascular treatment, angiography or anesthesia

  9. Design Schedule of evaluation following endovascular intervention

  10. Primary end point (recurrence rate) Angiographic recurrence (6 months or 18 months), with or without retreatment (independent core lab) SAH or mass effect Secondary end point (safety) Procedural safety Mortality rate Morbidity rate, possibly or probably related to aneurysm or its treatment (Adjudication Committee) Outcomes

  11. Randomization - Recruitment Stats TOTAL Subjects : 178; TOTAL Sites : 26 Semptember 15 2010

  12. Randomization - Recruitment Stats List of Sites TOTAL non-US : 10 TOTAL United States : 16 The site in red has withdrawn its participation

  13. Randomization - Recruitment Stats Performance of Sites per Country

  14. Demographics PRET-1; N = 91 PRET-2; N = 87

  15. Target Aneurysm Parameters PRET-1; N = 91 PRET-2; N = 87

  16. Severity Attribution Adverse Events AE Committee review on June 4, 2010 (145 enrolled): 48 Validated AEs

  17. Adverse Events

  18. Adverse Events Causality Attribution Categories: RT-S; strictly related to treatment: any M&M associated with a procedural event or complication. RT-P; possibly related to treatment: any M&M occuring within 30 days RA; related to aneurysm U; unrelated to the aneurysm or its treatment

  19. Adverse Events Severity/Causality distribution

  20. Adverse Events

  21. Randomization – Problems Problem preventing recruitment: • Cost of Hydrocoil Problems slowing recruitment: * • Not every eligible patient is recruited • Competition with other trials • Competition with other devices

  22. Thank you

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