Evidence map›Paper›PMID 34805915›Full record

ArticleJournal of interventional medicine2020

Safety and efficacy of the SeparGate™ balloon-guiding catheter in neurointerventional surgery: Study protocol of a prospective multicenter single-arm clinical trial.

Huan Liu, Tianxiao Li, Zhaoshuo Li, Liangfu Zhu, Yingkun He

Erratum issuedOpen access · diamondAbstract read
In one paragraph

Article in Journal of interventional medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 41% 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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Estimating the impact of balloon guide catheter with mechanical thrombectomy for acute ischemic stroke: A U.S. cost analysis.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025
    Article
  2. Article
  3. Article
  4. Safety and efficacy of the SeparGateJournal of interventional medicine · 2022
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Huan LiuDepartment of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Henan University People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease, China.
Tianxiao LiDepartment of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Henan University People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease, China.
Zhaoshuo LiDepartment of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Henan University People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease, China.
Liangfu ZhuDepartment of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Henan University People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease, China.
Yingkun HeDepartment of Cerebrovascular Disease, Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Henan University People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease, China.
Zhengzhou University · CNHenan Provincial People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe balloon-guiding catheter (BGC) reportedly reduces the number of retrievals and occurrence of distal emboli, achieving superior revascularization results and improved clinical outcomes in acute stroke. This study will aim to examine the efficacy and safety of the new SeparGate™ BGC.

designThis prospective multicenter single-arm clinical trial will aim to include 128 patients who fulfill its inclusion and exclusion criteria. All patients will receive endovascular interventional therapy with BGC assistance. The primary endpoint will be the immediate surgical success rate, while the secondary endpoint will be product performance. The safety evaluation will include serious adverse events such as puncture site hematoma and bleeding, cerebral vasospasm, vessel dissection, vessel perforation, air embolism, thrombus (acute or subacute), vessel occlusion, distal embolization, infection, adverse reaction to antiplatelet and anticoagulant drugs, intracranial hemorrhage, stroke, death, and device defect. DISCUSSION: The prospective multicenter trial will provide safety and efficacy information for the SeparGate™ BGC. Its findings will provide a clinical reference for endovascular adjuvant therapy of cerebrovascular disease.

trial registrationChiCTR1800014459.

Indexed as

BGCBlood flow blockCerebrovascular diseaseTrial

Identifiers

PMID34805915
PMCPMC8562254
OpenAlexW3013344284

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.