Femoral or Radial Approach in Coronary Chronic Total Occlusion

NCT ID: NCT03265769

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 610 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-08
• Study Completion Date: 2021-07-08

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.

Conditions

Chronic Coronary Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transradial approach

target vessel revascularization via radial access site is labeled as transradial approach

Group Type: ACTIVE_COMPARATOR

radial access site

Intervention Type: OTHER

radial route

Transfemoral approach

target vessel revascularization via femoral access site is labeled as transfemoral approach

Group Type: ACTIVE_COMPARATOR

femoral access site

Intervention Type: OTHER

femoral route

Interventions

radial access site

radial route

Intervention Type: OTHER

femoral access site

femoral route

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Acute coronary syndrome within 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acibadem University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sevket Gorgulu, MD

Role: STUDY_CHAIR

Acibadem University

Locations

Acibadem University

Istanbul, , Turkey (Türkiye)

Haseki Cradiology Institute

Istanbul, , Turkey (Türkiye)

Memorial Hospital

Istanbul, , Turkey (Türkiye)

Erciyes University

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 35450683 (View on PubMed)

Other Identifiers

Atadek2017/13

Identifier Type: -

Identifier Source: org_study_id