ArticleCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2022
PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.
Article in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04142541 (Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter, and a Novel Carotid Stent), which is not on this map. Cited by 3 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.
Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter, and a Novel Carotid Stent (PERFORMANCE 1 Trial)
Who cites it
3 citing papers in PubMed, 11 citations in OpenAlex.
- The efficacy of different types of cerebral embolic protection device during transcatheter aortic valve implantation: a meta-analysis.Frontiers in cardiovascular medicine · 2024Review
- Carotid artery interventions - endarterectomy versus stenting.AsiaIntervention · 2023Review
- PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2022Article
Corrections and comments
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Authors and funding
13 authors at 11 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis.
backgroundThe risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting.
methodsIn total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions versus a prespecified performance goal. Secondary endpoints included procedure success, device success, and target lesion revascularization.
resultsThe study population was predominantly male (74.6%) with a mean age of 69.3 ± 8.9 years and 67% of subjects met at least one criterion placing them at an elevated risk for adverse events following carotid endarterectomy. All patients were treated successfully with the study device. There were no deaths or strokes within 30 days of the index procedure. One subject (1.5%) experienced a non-ST elevation myocardial infarction at day 17. The primary endpoint was met with a 30-day major adverse events rate of 1.5% (1/67). Through 12-month follow-up, there were no strokes, neurological deaths, target lesion revascularizations, or instances of in-stent-restenosis.
conclusionsResults from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days. A large pivotal study is currently underway.
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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.