Evidence map›Paper›PMID 32690749›Full record

ArticleBMJ open2020

Complex Large-Bore Radial percutaneous coronary intervention: rationale of the COLOR trial study protocol.

Thomas A Meijers, Adel Aminian, Koen Teeuwen, Marleen van Wely, Thomas Schmitz, Maurits T Dirksen, Rene J van der Schaaf, Juan F Iglesias, Pierfrancesco Agostoni, Joseph Dens and 9 more

Registry-linked trialAbstract read
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03846752 (Complex Large-bore Radial PCI Trial Randomized Trial Reducing Access Site Complications With Slender Technology for Complex PCI), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT03846752 nacompletednot on this map

Complex Large-bore Radial PCI Trial Randomized Trial Reducing Access Site Complications With Slender Technology for Complex PCI

TypeinterventionalSponsorMaatschap Cardiologie ZwolleRan2019 to 2020Enrolled388ConditionsComplex Coronary LesionsArmsradial artery access for complex PCI, femoral artery access for complex PCI
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

19 authors.

Thomas A Meijers *Cardiology, Isala Hospitals, Zwolle, The Netherlands.ORCID 0000-0002-4298-1607
Adel Aminian *Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Wallonie, Belgium.
Koen TeeuwenCardiology, Catharina Hospital, Eindhoven, Noord Brabant, The Netherlands.
Marleen van WelyCardiology, Radboudumc, Nijmegen, Gelderland, The Netherlands.
Thomas SchmitzCardiology, Elisabeth-Krankenhaus-Essen GmbH, Essen, Nordrhein-Westfalen, Germany.
Maurits T DirksenCardiology, Noordwest Ziekenhuisgroep, Alkmaar, Noord-Holland, The Netherlands.
Rene J van der SchaafCardiology, OLVG, Amsterdam, Noord-Holland, The Netherlands.
Juan F IglesiasCardiology, Geneva University Hospitals, Geneve, Genève, Switzerland.
Pierfrancesco AgostoniCardiology, ZNA, Antwerpen, Belgium.
Joseph DensCardiology, Ziekenhuis Oost-Limburg, Genk, Limburg, Belgium.
Paul KnaapenCardiology, Amsterdam UMC - Locatie VUMC, Amsterdam, Noord-Holland, The Netherlands.
Sudhir RathoreCardiology, Frimley Health NHS Foundation Trust, Frimley, Surrey, UK.
Jan Paul OttervangerCardiology, Isala Hospitals, Zwolle, The Netherlands.
Jan-Henk E DambrinkCardiology, Isala Hospitals, Zwolle, The Netherlands.
Vincent RoolvinkCardiology, Isala Hospitals, Zwolle, The Netherlands.
A T Marcel GosselinkCardiology, Isala Hospitals, Zwolle, The Netherlands.
Renicus S HermanidesCardiology, Isala Hospitals, Zwolle, The Netherlands.
Niels van RoyenCardiology, Radboudumc, Nijmegen, Gelderland, The Netherlands.
Maarten A H van LeeuwenCardiology, Isala Hospitals, Zwolle, The Netherlands m.a.h.van.leeuwen@isala.nl.ORCID 0000-0002-4264-4280

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe radial artery has become the standard access site for percutaneous coronary intervention (PCI) in stable coronary artery disease and acute coronary syndrome, because of less access site related bleeding complications. Patients with complex coronary lesions are under-represented in randomised trials comparing radial with femoral access with regard to safety and efficacy. The femoral artery is currently the most applied access site in patients with complex coronary lesions, especially when large bore guiding catheters are required. With slender technology, transradial PCI may be increasingly applied in patients with complex coronary lesions when large bore guiding catheters are mandatory and might be a safer alternative as compared with the transfemoral approach. METHODS AND ANALYSIS: A total of 388 patients undergoing complex PCI will be randomised to radial 7 French access with Terumo Glidesheath Slender (Terumo, Japan) or femoral 7 French access as comparator. The primary outcome is the incidence of the composite end point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Procedural success and major adverse cardiovascular events up to 1 month will also be compared between both groups. ETHICS AND DISSEMINATION: Ethical approval for the study was granted by the local Ethics Committee at each recruiting center ('Medisch Ethische Toetsing Commissie Isala Zwolle', 'Commissie voor medische ethiek ZNA', 'Comité Medische Ethiek Ziekenhuis Oost-Limburg', 'Comité d'éthique CHU-Charleroi-ISPPC', 'Commission cantonale d'éthique de la recherche CCER-Republique et Canton de Geneve', 'Ethik Kommission de Ärztekammer Nordrhein' and 'Riverside Research Ethics Committee'). The trial outcomes will be published in peer-reviewed journals of the concerned literature. TRIAL REGISTRATION NUMBER: NCT03846752.

Indexed as

Percutaneous Coronary InterventionRadial ArteryCoronary AngiographyFemoral ArteryHumansJapanTreatment Outcomecardiologycoronary heart diseasecoronary intervention

Identifiers

PMID32690749
PMCPMC7375502

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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.