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NCT03265769

Femoral or Radial Approach in Coronary Chronic Total Occlusion

Completed NA Last updated 13 September 2021
What this trial tests

NA trial testing radial access site in Chronic Coronary Occlusion in 610 participants. Completed in 8 July 2021.

Timeline
8 August 2017
Primary endpoint
8 July 2021
8 July 2021

Quick facts

Lead sponsorAcibadem University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment610
Start date8 August 2017
Primary completion8 July 2021
Estimated completion8 July 2021
Sites4 locations across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Acibadem University

Who can join

Adults 18 to 90, any sex, with Chronic Coronary Occlusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly performed using bilateral transfemoral access and 8 French guiding catheters. However, transfemoral approach (TFA) is associated with higher risk of vascular access complications.5 It has been reported that using transradial approach (TRA) reduces vascular complications and may be associated with a better clinical outcome. Transradial access is also used in complex PCI interventions.There is a growing body of evidence regarding the use of this approach also in CTO procedures. In available literature, all studies comparing TRA vs. TFA in CTO consisted of single center and single operator experience. Besides, none of them is randomized. To fill in the gap, we sought to examine the technique and outcomes of transradial vs. transfemoral CTO PCI in a contemporary multicenter randomized study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial.
    Gorgulu S, Kalay N, Norgaz T, Kocas C, et al · · 2022 · cited 25× · PMID 35450683 · DOI 10.1016/j.jcin.2022.02.012

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