Trial reportJournal of neurointerventional surgery2017
Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study.
Trial report in Journal of neurointerventional surgery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02390037 (Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study), which is not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.
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.
Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Outcome of Flow Diverters with Surface Modifications in Treatment of Cerebral Aneurysms: Systematic Review and Meta-analysis.AJNR. American journal of neuroradiology · 2021Pooled it
- Angiographic and clinical outcomes from 396 aneurysms treated with the pipeline flex embolization device with shield technology.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026Article
- Stent-Assisted Coiling vs. Flow Diversion in Unruptured Anterior Circulation Aneurysms: A Single-Center Cohort Study.Brain sciences · 2025Article
- The Pipeline embolization device for the treatment of intracranial aneurysms in pediatric patients with tuberous sclerosis complex: illustrative cases.Journal of neurosurgery. Case lessons · 2024Article
- Multicenter Experience with the Pipeline Flex and Vantage with Shield Technology for Intracranial Aneurysm Treatment.AJNR. American journal of neuroradiology · 2024Observational
- Initial Experience with the Derivo 2Heal Flow Diverter under Standard or Reduced-Dose Single Antiplatelet Therapy.AJNR. American journal of neuroradiology · 2024Article
- Technical success, procedural safety, and efficacy of the Silk Vista Baby in the treatment of cerebral aneurysms over a mid-to-long-term follow-up.Frontiers in neurology · 2024Article
- Silk + flow-diverter stent for the treatment of intracranial aneurysms associated with balloon angioplasty: A retrospective study.Surgical neurology international · 2023Article
- Safety and Clinical Effectiveness of Pipeline Shield Device for Intracranial Aneurysms in an Australian Cohort (SCOPE-AUS).Stroke (Hoboken, N.J.) · 2022Article
- Use of a p64 MW Flow Diverter with Hydrophilic Polymer Coating (HPC) and Prasugrel Single Antiplatelet Therapy for the Treatment of Unruptured Anterior Circulation Aneurysms: Safety Data and Short-term Occlusion Rates.Cardiovascular and interventional radiology · 2022Article
- Early clinical experience with the p48MW HPC and p64MW HPC flow diverters in the anterior circulation aneurysm using single anti-platelet treatment.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2022Article
- Dataset on flow diversion procedures performed with the Pipeline Embolization Device, Pipeline Flex, and Surpass Streamline for intracranial aneurysms.Data in brief · 2022Article
- The Silk Vista Baby - The UK experience.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2022Article
- Early clinical experience of using the Surpass Evolve flow diverter in the treatment of intracranial aneurysms.Neuroradiology · 2022Article
- Successful flow diversion treatment of ruptured infectious middle cerebral artery aneurysms with the use of Pipeline Flex with Shield technology.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2021Article
- Aneurysm Treatment in Acute SAH with Hydrophilic-Coated Flow Diverters under Single-Antiplatelet Therapy: A 3-Center Experience.AJNR. American journal of neuroradiology · 2021Article
- Treatment of Intracranial Aneurysms Using the New Silk Vista Flow Diverter: Safety Outcomes at Short-Term Follow-Up.Frontiers in neurology · 2021Article
- Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study.Journal of neurointerventional surgery · 2020Observational
- Mechanism of Action and Biology of Flow Diverters in the Treatment of Intracranial Aneurysms.Neurosurgery · 2020Review
- Pipeline Flex Embolization Device (PED Flex) for the treatment of intracranial aneurysms: Periprocedural outcomes and first-year angiographic resultsTurkish journal of medical sciences · 2019Article
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background and purposeThe Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer. MATERIALS AND
methodsThe Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1 year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes.
resultsFifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15 mm. Thirty-eight aneurysms (76%) were small (<10 mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period.
conclusionsThe results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods. CLINICAL
trial registrationNCT02390037.
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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.