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OpenTrials
Completed

NCT Number: NCT03265769

Femoral or Radial Approach in Coronary Chronic Total Occlusion

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.

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Key information

Conditions

Chronic Coronary Occlusion

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem University, Istanbul, Turkey (Türkiye)

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About this study

All consecutive patients referred for CTO PCI between August 2017 and July 2021 at Acibadem University Kocaeli Acibadem Hospital, Kocaeli; Erciyes University Medical Faculty, Kayseri; Istanbul University Cerrahpasa Medical Faculty, Haseki Cardiology Institute; Istanbul; Memorial Bahcelievler Hospital, Istanbul were screened for enrollment in the study. The exclusion criteria included: (a) any acute coronary syndrome within 3 months; (b) severe heart failure issues; (c)severe renal failure (d) failure to provide written informed consent.The radial access group consisted of patients with single or bi-radial approach. Any femoral artery puncture was considered a femoral case. For example, a crossover from any radial to femoral access was considered a femoral case. Procedures were performed by 4 interventional cardiologists, who are dedicated radial operators, at 4 different centers. The protocol was approved by the institutional review board and all patients provided written informed consent.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient with coronary total occlusion >3 months and indication for intervention

Exclusion criteria

  • Acute coronary syndrome within 3 months

Treatment and study plan

radial access site

Other

radial route

femoral access site

Other

femoral route

Primary outcomes

  1. Procedural success

    Time frame: 24 hours

    Technical success without any in-hospital event

Secondary outcomes

  1. Major access site complications

    Time frame: 24 hours

    Major bleeding, vascular complication requiring intervention and hematomas ≥ 10 cm

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial (FORT CTO TRIAL)

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2017
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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