Clinical trial NCT03393052: Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy
Official title: Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Vascular Access Complication
Keywords: L-RECORD
Radial
Femoral
CABG
coronary artery bypass graft
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
Collaborators: name: Korgialenio-Benakio Red Cross Hospital
name: University General Hospital of Heraklion
name: AHEPA University Hospital
First posted: 2018-01-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of CABG surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study) expanding the documented benefits of radial access to this group of patients.

Detailed description: Patients from 4 different centers with a history of CABG are randomized 1:1 to left radial or femoral access. Based on the literature, a randomized study sample of a total of 150 patients was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%, beta = 10% (power 90%) and non-inferiority limit Δ = 5 minutes. The primary endpoint of the study is the time it takes after placing the sheath at the initial puncture site until the completion of the diagnostic procedure (Net procedure time). Secondary endpoints include total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of contrast used, possible vascular complications, major cardiovascular events and need for crossover access site.

Eligibility criteria: Inclusion Criteria:

1. Age over 18 years
2. Written informed consent
3. Clinical indication for coronary angiography in a patient with prior history of CABG
4. Left radial artery has not been used as a graft during CABG

Exclusion Criteria:

1. Age over 90 years
2. Patient's refusal to participate in the study
3. Hemodynamic instability of the patient
4. Failure to place a sheath at the randomization access site
5. Arteriovenous fistula at the left upper limb
6. Use of right internal mammary artery as a graft during CABG
7. Creatinine clearance \<30 ml/min

Primary outcomes:
measure: Net Procedure Time
timeFrame: 24 hours
Secondary outcomes:
measure: Total Procedure Time
timeFrame: 24 hours
measure: Fluoroscopy Time
timeFrame: 24 hours
measure: Dose Area Product
timeFrame: 24 hours
measure: Contrast Volume
timeFrame: 24 hours
measure: Crossover access site
timeFrame: 24 hours
measure: Major Cardiovascular Events
timeFrame: 24 hours
measure: Vascular Complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaia
Study officials:
affiliation: University Hospital of Patras
name: George Hahalis, Prof.
role: STUDY_DIRECTOR
affiliation: University Hospital of Patras
name: Periklis Davlouros, Ass. Prof.
role: STUDY_DIRECTOR
affiliation: University Hospital of Patras
name: Grigorios Tsigkas
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Patras
name: Athanasios Makris
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Koutouzis M, Matejka G, Olivecrona G, Grip L, Albertsson P. Radial vs. femoral approach for primary percutaneous coronary intervention in octogenarians. Cardiovasc Revasc Med. 2010 Apr-Jun;11(2):79-83. doi: 10.1016/j.carrev.2009.04.107.
citation: Baker NC, O'Connell EW, Htun WW, Sun H, Green SM, Skelding KA, Blankenship JC, Scott TD, Berger PB. Safety of coronary angiography and percutaneous coronary intervention via the radial versus femoral route in patients on uninterrupted oral anticoagulation with warfarin. Am Heart J. 2014 Oct;168(4):537-44. doi: 10.1016/j.ahj.2014.06.016. Epub 2014 Jul 3.
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