ArticleJournal of neurointerventional surgery2022
Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device.
Article in Journal of neurointerventional surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06201598 (Prospective, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Endovascular Treatment in Patients With Cerebral Aneurysms Using P64 and P48 Flow-Diverter Stents), which is not on this map. Cited by 21 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Endovascular Treatment in Patients With Cerebral Aneurysms Using P64 and P48 Flow-Diverter Stents
Who cites it
21 citing papers in PubMed, 36 citations in OpenAlex.
- FloWise Flow Diverter for Treatment of Unruptured Wide-Neck Intracranial Aneurysms: A Prospective, Multicenter, Single-Arm, Open-Label, Pivotal Study.Korean journal of radiology · 2025Trial
- Defining biomaterial-driven design principles for bioabsorbable flow diverters: current state and perspectives.Bioactive materials · 2027Review
- Flow Diversion for Anterior Communicating Artery Aneurysms: Systematic Review and Meta-Analysis.Stroke (Hoboken, N.J.) · 2026Article
- Comaneci stent-angioplasty for the optimization of inadequately deployed flow diverter stents.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026Article
- Multicenter study of the safety and effectiveness of intracranial aneurysm treatment with the p64MW-HPC flow modulation device.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026Article
- Flow diverter surface modifications for aneurysm treatment: A review of the mechanisms and data behind existing technologies.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026Review
- Efficacy and safety of p48 flow diverters in the treatment of intracranial aneurysms: A systematic review and Meta-Analysis.Neuroradiology · 2025Review
- The use of FD-HPC in Ruptured and Unruptured Aneurysms, the Italian Dataset (RUAID): Preliminary results on feasibility and safety.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025Article
- The DERIVO 2 Heal Embolization Device in the Treatment of Ruptured and Unruptured Intracranial Aneurysms: a Retrospective Multicenter Study.Clinical neuroradiology · 2025Article
- Multicenter study of HPC coated p48 and p64 flow diverters for treatment of intracranial aneurysms under dual antiplatelet therapy.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025Article
- Treatment of Unruptured Small and Medium-Sized Wide Necked Aneurysms Using the 64-Wire Surpass Evolve: A Subanalysis From the SEASE International Registry.Journal of the American Heart Association · 2024Observational
- The DERIVO®2 Embolization Device in the treatment of ruptured and unruptured intracranial aneurysms: A multicenter analysis.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2024Article
- Use of the Tubridge flow diverter in the treatment of intracranial aneurysms: a single center experience.Scientific reports · 2024Article
- Systematic Review and Meta-Analysis of Endovascular Therapy Effectiveness for Unruptured Saccular Intracranial Aneurysms.Stroke (Hoboken, N.J.) · 2024Article
- Innovations in intracranial aneurysm treatment: a pilot study on the Choydar flow diverter.Frontiers in neurology · 2024Article
- Safety and efficacy of the surpass streamline for intracranial aneurysms (SESSIA): A multi-center US experience pooled analysis.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2023Article
- Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design.Journal of neurointerventional surgery · 2023Article
- And don't forget your anti in-stent stenosis pill! Commentary on 'Factors associated with in-stent stenosis after cerebral aneurysm embolization using a Pipeline embolization device' by Flores-Milan et al.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2023Article
- Intrasaccular neck-bridging: A technical note on Nautilus-assisted coiling of wide-necked cerebral aneurysms. Feasibility study, immediate and early angiographic results.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2022Article
- Will Coiling Survive through the Next Decade?Journal of clinical medicine · 2022Article
Corrections and comments
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Authors and funding
32 authors at 20 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe use of flow diversion to treat intracranial aneurysms has increased in recent years.
objectiveTo assess the safety and angiographic efficacy of the p64 flow modulation device.
methodsDiversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3-6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography.
resultsA total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10).
conclusionsDiversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.