An interventional study of radial access site and femoral access site in Chronic Coronary Occlusion, sponsored by Acibadem University. Completed at 4 sites in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-09-13.
Sponsored by Acibadem University · Not applicable, Interventional, and Treatment
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.
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.
71 studies on the registry are indexed under Coronary Occlusion; 11 are open to participants now.
This study's enrollment of 610 is above the median of 135 across 45 interventional studies indexed under Coronary Occlusion.
Browse Coronary Occlusion studies →Acibadem University is the lead sponsor of 220 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
target vessel revascularization via radial access site is labeled as transradial approach
Other: radial access site
target vessel revascularization via femoral access site is labeled as transfemoral approach
Other: femoral access site
radial route
femoral route
Procedural success
Technical success without any in-hospital event
Time frame: 24 hours
Major access site complications
Major bleeding, vascular complication requiring intervention and hematomas ≥ 10 cm
Time frame: 24 hours
Ran from Aug 2017 to primary completion in Jul 2021, 47 months.
Of 16 interventional studies with no phase under Coronary Occlusion, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 69. This study's 47 months is close to that.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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