Clinical trial NCT03265769: Femoral or Radial Approach in Coronary Chronic Total Occlusion
Official title: Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial (FORT CTO TRIAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Coronary Occlusion
Keywords: Femoral approach
Radial approach
Chronic total occlusion
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Acute coronary syndrome within 3 months

Primary outcomes:
measure: Procedural success
timeFrame: 24 hours
Secondary outcomes:
measure: Major access site complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acibadem University
city: Istanbul
country: Turkey
facility: Haseki Cradiology Institute
city: Istanbul
country: Turkey
facility: Memorial Hospital
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
affiliation: Acibadem University
name: Sevket Gorgulu, MD
role: STUDY_CHAIR
References:
citation: 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.