Femoral or Radial Approach in Coronary Chronic Total Occlusion

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Coronary Occlusion
• Intervention / Treatment: Other: radial access site; Other: femoral access site

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 610
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Memorial Hospital
  • Istanbul, Turkey
    • Haseki Cradiology Institute
  • Kayseri, Turkey
    • Erciyes University
  • İstanbul, Turkey
    • Acibadem University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Acute coronary syndrome within 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Transradial approach; target vessel revascularization via radial access site is labeled as transradial approach	Other: radial access site; radial route
ACTIVE_COMPARATOR: Transfemoral approach; target vessel revascularization via femoral access site is labeled as transfemoral approach	Other: femoral access site; femoral route

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Technical success without any in-hospital event	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major access site complications	Major bleeding, vascular complication requiring intervention and hematomas ≥ 10 cm	24 hours

Collaborators and Investigators

• Sponsor: Acibadem University
• Investigators: Study Chair: Sevket Gorgulu, MD, Acibadem University

Publications and helpful links

General Publications

• Gorgulu S, Kalay N, Norgaz T, Kocas C, Goktekin O, Brilakis ES. Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial. JACC Cardiovasc Interv. 2022 Apr 25;15(8):823-830. doi: 10.1016/j.jcin.2022.02.012. Erratum In: JACC Cardiovasc Interv. 2022 Jul 11;15(13):1396.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 8, 2017
• Primary Completion (ACTUAL): July 8, 2021
• Study Completion (ACTUAL): July 8, 2021

Study Registration Dates

• First Submitted: August 27, 2017
• First Submitted That Met QC Criteria: August 27, 2017
• First Posted (ACTUAL): August 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Chronic total occlusion; Femoral approach; Radial approach
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Occlusion
• Other Study ID Numbers: Atadek2017/13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No