Femoral or Radial Approach in Coronary Chronic Total Occlusion
1 other identifier
interventional
610
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2017
CompletedFirst Submitted
Initial submission to the registry
August 27, 2017
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2021
CompletedSeptember 13, 2021
September 1, 2021
3.9 years
August 27, 2017
September 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Procedural success
Technical success without any in-hospital event
24 hours
Secondary Outcomes (1)
Major access site complications
24 hours
Study Arms (2)
Transradial approach
ACTIVE COMPARATORtarget vessel revascularization via radial access site is labeled as transradial approach
Transfemoral approach
ACTIVE COMPARATORtarget vessel revascularization via femoral access site is labeled as transfemoral approach
Interventions
Eligibility Criteria
You may qualify if:
- Any patient with coronary total occlusion \>3 months and indication for intervention
You may not qualify if:
- Acute coronary syndrome within 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Acibadem University
Istanbul, Turkey (Türkiye)
Haseki Cradiology Institute
Istanbul, Turkey (Türkiye)
Memorial Hospital
Istanbul, Turkey (Türkiye)
Erciyes University
Kayseri, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 35450683DERIVED
Study Officials
- STUDY CHAIR
Sevket Gorgulu, MD
Acibadem University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2017
First Posted
August 29, 2017
Study Start
August 8, 2017
Primary Completion
July 8, 2021
Study Completion
July 8, 2021
Last Updated
September 13, 2021
Record last verified: 2021-09