Evidence map›Paper›PMID 29628946›Full record

ArticleInterventional neurology2018

A Prospective Multicenter Trial of the TransForm Occlusion Balloon Catheter: Trial Design and Results.

M Asif Taqi, Syed A Quadri, Ajit S Puri, Brian F Fitzsimmons, Jianhua Nancy Jin, Ansaar T Rai, Curtis A Given, Javier Masso, Ciaran J Powers, Joey D English and 1 more

Open access · bronzeAbstract read
In one paragraph

Article in Interventional neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.5field-weighted citation impact, top 30% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Evaluation of the differences in pressure applied to the vessel wall by different types of balloon remodeling microcatheters in an experimental model.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2022
    Article
  4. Article
  5. Article
  6. Review
  7. 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

11 authors at 10 institutions in 2 countries.

M Asif TaqiCalifornia Institute of Neuroscience and Los Robles Hospital and Medical Center, Thousand Oaks, California, USA.
Syed A QuadriCalifornia Institute of Neuroscience and Los Robles Hospital and Medical Center, Thousand Oaks, California, USA.
Ajit S PuriDepartment of Radiology, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA.
Brian F FitzsimmonsDepartment of Neurology, Neurosurgery and Radiology, Medical College of Wisconsin and Froedtert Hospital, Milwaukee, Wisconsin, USA.
Jianhua Nancy JinDepartment of Biostatistics, Stryker Neurovascular, Fremont, California, USA.
Ansaar T RaiDepartment of Interventional Neuroradiology, West Virginia University Hospital, Morgantown, West Virginia, USA.
Curtis A GivenBaptist Health Lexington/Central Baptist Hospital, Lexington, Kentucky, USA.
Javier MassoDepartment of Neuroradiology, Hospital Universitario Donostia, San Sebastian, Spain.
Ciaran J PowersDepartment of Neurological Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Joey D EnglishNeurointerventional Surgery, California Pacific Medical Center, San Francisco, California, USA.
Osama O ZaidatDepartment of Endovascular Neurosurgery and Stroke, St. Vincent Mercy Medical Center, Toledo, Ohio, USA.
Los Robles Hospital & Medical Center · USBiogipuzkoa Health Research Institute · ESCalifornia Pacific Medical Center · USCentral Baptist Hospital · USMedical College of Wisconsin · USMercy St. Vincent Medical Center · USNeurological Surgery · USStryker (United States) · USUMass Memorial Medical Center · USWest Virginia University Hospitals · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeAdjunctive treatments like balloon-assisted coil embolization (BACE) and stent-assisted coil embolization play a major role in the treatment of wide-neck and large intracranial aneurysms. The TransForm™ Occlusion Balloon Catheter (TOBC) registry is intended to evaluate the safety, efficacy, and efficiency of BACE using the TOBC. METHOD AND STUDY

designThe TOBC registry is a prospective multicenter registry trial. Seven sites in the USA and 1 site in Spain participated and enrolled 81 patients.

resultsThe performance and safety of the TOBC was evaluated based on scoring for different variables. Scores were measured using a semiquantitative rating scale (1 = excellent, 5 = poor). The mean scores for these variables were as follows: visibility under fluoroscopy, 1.8; ability to reach the intended site, 1.6; stability during first positioning, 1.5; stability during inflation, 1.6; stability during deflation, 1.6; ability to temporarily stop flow, 1.6; and ability to assist in coil embolization, 1.7. The mean inflation and deflation times were 4.9 and 5.6 s, respectively. Complete obliteration of the aneurysm (Raymond class I) was achieved in 69.4% of the BACE cases. Thrombus formation occurred in 4/81 (4.8%) of the cases. In all cases, the thrombus resolved with medications, no patient suffered an infarction, and an underlying hypercoagulable state from subarachnoid hemorrhage was considered a contributing factor. Vessel rupture occurred in 1/81 (1.2%) of the cases, but was unrelated to TOBC use.

conclusionBACE using the TOBC is safe and effective. All variables assessed for performance showed good-to-excellent results.

Indexed as

Balloon-assisted coil embolizationBalloon-assisted coilingIntracranial aneurysmsSingle-lumen balloonTransForm Occlusion Balloon CatheterTrial

Identifiers

PMID29628946
PMCPMC5881141
OpenAlexW2769368149

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.