Femoral or Radial Approach in Coronary Chronic Total Occlusion

Chronic Coronary Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265769
• Other study ID #: Atadek2017/13
• Status: Completed
• Phase: N/A
• Start date: August 8, 2017
• Est. completion date: July 8, 2021

Study information

• Verified date: September 2021
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Acute coronary syndrome within 3 months

Related Conditions & MeSH terms

• Chronic Coronary Occlusion
• Coronary Occlusion

Intervention

Other:
• radial access site
radial route
• femoral access site
femoral route

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul
Turkey	Haseki Cradiology Institute	Istanbul
Turkey	Memorial Hospital	Istanbul
Turkey	Erciyes University	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success	Technical success without any in-hospital event	24 hours
Secondary	Major access site complications	Major bleeding, vascular complication requiring intervention and hematomas = 10 cm	24 hours