NCT03393052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

December 31, 2017

Last Update Submit

June 3, 2018

Conditions

Coronary Artery DiseaseVascular Access Complication

Keywords

L-RECORDRadialFemoralCABGcoronary artery bypass graft

Outcome Measures

Primary Outcomes (1)

  • Net Procedure Time

    The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography

    24 hours

Secondary Outcomes (7)

  • Total Procedure Time

    24 hours

  • Fluoroscopy Time

    24 hours

  • Dose Area Product

    24 hours

  • Contrast Volume

    24 hours

  • Crossover access site

    24 hours

  • +2 more secondary outcomes

Study Arms (2)

Left Radial access

ACTIVE COMPARATOR

Left Radial approach for coronary angiography in patients with prior history of CABG surgery

Procedure: Coronary Angiography

Femoral access

ACTIVE COMPARATOR

Femoral approach for coronary angiography in patients with prior history of CABG surgery

Procedure: Coronary Angiography

Interventions

Coronary AngiographyPROCEDURE

Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery

Femoral accessLeft Radial access

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

Location

Related Publications (8)

  • Pancholy SB, Joshi P, Shah S, Rao SV, Bertrand OF, Patel TM. Effect of Vascular Access Site Choice on Radiation Exposure During Coronary Angiography: The REVERE Trial (Randomized Evaluation of Vascular Entry Site and Radiation Exposure). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1189-1196. doi: 10.1016/j.jcin.2015.03.026. Epub 2015 Jul 22.

    PMID: 26210808BACKGROUND

  • Koltowski L, Koltowska-Haggstrom M, Filipiak KJ, Kochman J, Golicki D, Pietrasik A, Huczek Z, Balsam P, Scibisz A, Opolski G. Quality of life in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention--radial versus femoral access (from the OCEAN RACE Trial). Am J Cardiol. 2014 Aug 15;114(4):516-21. doi: 10.1016/j.amjcard.2014.05.030. Epub 2014 Jun 6.

    PMID: 25015695BACKGROUND

  • Michael TT, Alomar M, Papayannis A, Mogabgab O, Patel VG, Rangan BV, Luna M, Hastings JL, Grodin J, Abdullah S, Banerjee S, Brilakis ES. A randomized comparison of the transradial and transfemoral approaches for coronary artery bypass graft angiography and intervention: the RADIAL-CABG Trial (RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention). JACC Cardiovasc Interv. 2013 Nov;6(11):1138-44. doi: 10.1016/j.jcin.2013.08.004. Epub 2013 Oct 16.

    PMID: 24139930BACKGROUND

  • Louvard Y, Lefevre T, Allain A, Morice M. Coronary angiography through the radial or the femoral approach: The CARAFE study. Catheter Cardiovasc Interv. 2001 Feb;52(2):181-7. doi: 10.1002/1522-726x(200102)52:23.0.co;2-g.

    PMID: 11170325BACKGROUND

  • 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.

    PMID: 20347796BACKGROUND

  • 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.

    PMID: 25262264BACKGROUND

  • Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.

    PMID: 21470671BACKGROUND

  • Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1.

    PMID: 19081409BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • George Hahalis, Prof.

    University Hospital of Patras

    STUDY DIRECTOR

  • Periklis Davlouros, Ass. Prof.

    University Hospital of Patras

    STUDY DIRECTOR

  • Grigorios Tsigkas

    University Hospital of Patras

    PRINCIPAL INVESTIGATOR

  • Athanasios Makris

    University Hospital of Patras

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

December 31, 2017

First Posted

January 8, 2018

Study Start

January 20, 2017

Primary Completion

May 15, 2018

Study Completion

May 15, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

GR(1)