Femoral or Radial Approach in Coronary Chronic Total Occlusion

Not Applicable

Completed

• Conditions: Chronic Coronary Occlusion
• Interventions: Other: femoral access site; Other: radial access site

• Registration Number: NCT03265769
• Lead Sponsor: Acibadem University

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.

Study Timeline

• Study Start: 2017-08-08
• Study First Submitted: 2017-08-27
• Study First Submitted QC: 2017-08-27
• Study First Posted: 2017-08-29
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

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

Exclusion Criteria

• Acute coronary syndrome within 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transfemoral approach	femoral access site	target vessel revascularization via femoral access site is labeled as transfemoral approach
Transradial approach	radial access site	target vessel revascularization via radial access site is labeled as transradial approach

Primary Outcome Measures

Name	Time	Method
Procedural success	24 hours	Technical success without any in-hospital event

Secondary Outcome Measures

Name	Time	Method
Major access site complications	24 hours	Major bleeding, vascular complication requiring intervention and hematomas ≥ 10 cm

Trial Locations

Locations (4)

Acibadem University; 🇹🇷 İstanbul, Turkey

Memorial Hospital; 🇹🇷 Istanbul, Turkey

Haseki Cradiology Institute; 🇹🇷 Istanbul, Turkey

Erciyes University; 🇹🇷 Kayseri, Turkey