Evidence map›Paper›PMID 33593799›Full record

ArticleJournal of neurointerventional surgery2022

Periprocedural safety of saccular aneurysm embolization with the Penumbra SMART Coil System: a SMART registry subset analysis.

Robert M Starke, Min S Park, Richard Bellon, Bradley Bohnstedt, Clemens M Schirmer, Reade De Leacy, David Fiorella, Albert J Yoo, Alejandro M Spiotta, SMART Registry Investigators

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

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 NCT02729740 (SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT02729740 nacompletednot on this map

SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System

TypeinterventionalSponsorPenumbra Inc.Ran2016 to 2019Enrolled995ConditionsIntracranial AneurysmArmsPenumbra Smart Coil, Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Single-stage endovascular treatment in aneurysmal subarachnoid haemorrhage with multiple intracranial aneurysms: Systematic review of the literature and multicentric retrospective experience.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026
    Pooled it
  2. Article
  3. Observational
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 1 country.

Robert M StarkeNeurological Surgery, University of Miami Hospital, Miami, Florida, USA.
Min S ParkNeurosurgery, University of Virginia, Charlottesville, Virginia, USA.
Richard BellonInterventional Neuroradiology, Radiology Imaging Associates, Englewood, Colorado, USA.
Bradley BohnstedtDepartment of Neurological Surgery, Oklahoma University Medical Center, Oklahoma City, Oklahoma, USA.ORCID http://orcid.org/0000-0001-6254-2313
Clemens M SchirmerNeurosurgery, Geisinger Health System, Danville, Pennsylvania, USA.
Reade De LeacyNeurosurgery and Radiology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.ORCID http://orcid.org/0000-0001-9447-5338
David FiorellaNeurosurgery, Stony Brook University Medical Center, Stony Brook, New York, USA.ORCID http://orcid.org/0000-0002-2677-8780
Albert J YooInterventional Neuroradiology, Texas Stroke Institute, Dallas-Fort Worth, Texas, USA.
Alejandro M SpiottaNeurosurgery, Medical University of South Carolina, Charleston, South Carolina, USA spiotta@musc.edu.
SMART Registry Investigators
Geisinger Health System · USIcahn School of Medicine at Mount Sinai · USMedical University of South Carolina · USRadiology Associates · USStony Brook University Hospital · USUniversity Medical Center · USUniversity of Miami Hospital · USUniversity of Virginia · US

Funding

Miami Clinical and Translational Science InstituteUL1TR002736 · NCATS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI CARRASQUILLO, OLVEEN, KOBETZ, ERIN N · 2018 to 2022
$23.2M
Institutional Career Development CoreKL2TR002737 · NCATS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI RUNDEK, TATJANA, SCOTT, GWENDOLYN BARBARA · 2018 to 2022
$3.6M
Endothelial cell dysfunction in cerebral aneurysm pathogenesisR01NS111119 · NINDS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI STARKE, ROBERT MICHAEL · 2020 to 2024
$2.4M
NCATS NIH HHS KL2 TR002737NCATS NIH HHS UL1 TR002736NINDS NIH HHS R01 NS111119
6 · The paper itself

Abstract

backgroundUsing data from the SMART registry, we report on periprocedural safety of the Penumbra SMART Coil System for endovascular coil embolization of saccular intracranial aneurysms.

methodsThe SMART registry was a prospective, multi-center registry of site standard of care endovascular coiling procedures performed using at least 75% Penumbra SMART Coil, PC400, and/or POD coils. This subset analysis reports on the periprocedural safety outcomes of the saccular intracranial aneurysm cohort. Predictors of rupture/re-rupture or perforation (RRP), thromboembolic complications, and device- or procedure-related adverse events (AEs) were determined in univariate and multivariate analysis.

resultsBetween June 2016 and August 2018, 851 saccular aneurysm patients (31.0%, 264/851 ruptured) were enrolled across 66 North American centers. Clinically significant (ie, a serious adverse event) RRP occurred in 2.0% (17/851) of cases - 1.9% (5/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Clinically significant thromboembolic events occurred in 3.1% (26/851) of cases - 5.3% (14/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Multivariate predictors of periprocedural RRP were increased packing density and adjunctive treatment with a balloon. For periprocedural thromboembolic events, multivariate predictors were bifurcation location and ruptured status. For device- or procedure-related AEs, multivariate predictors were bifurcation location and adjunctive treatment with stent or balloon.

conclusionThe low rates of thromboembolic complications and RRP events demonstrate the adequate safety profile of the SMART Coil System to treat cerebral aneurysms in routine clinical practice. TRIAL REGISTRATION NUMBER: NCT02729740.

Indexed as

Aneurysm, RupturedEmbolization, TherapeuticIntracranial AneurysmHumansProspective StudiesRegistriesRetrospective StudiesStentsTreatment Outcomeaneurysmcoilcomplicationdeviceintervention

Identifiers

PMID33593799
PMCPMC8785012
OpenAlexW3130645107

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.