NCT05626660

Brief Summary

Our aim is to compare between right and left radial approach in patients undergoing percutaneous coronary procedures regarding feasibility and complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

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

First Submitted

Initial submission to the registry

November 3, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

June 4, 2025

Status Verified

November 1, 2024

Enrollment Period

2.1 years

First QC Date

November 3, 2022

Last Update Submit

June 2, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Comparison between right and left radial approach in patients undergoing percutaneous coronary Procedures , is there is difference in tortuosity of the radial and subclavian arteries between both approaches ?

    To compare the incidence of tortuosity in the radial and subclavian arteries between the right vs left radial approach. .

    Baseline

  • Comparison between right and left radial approach in patients undergoing percutaneous coronary Procedures regarding easiness of cannulation of left main coronary artery and right coronary artery tortuosity by assessing time needed for cannulation

    To compare the easiness of cannulation of left main (LM ) coronary artery and right coronary artery (RCA) via the two approaches by assessing time needed by the guiding wire and catheter to reach the ostia of either the left main coronary artery and right coronary artery .

    baseline

  • Comparison between right and left radial approach in patients undergoing percutaneous coronary Procedures , is there is possible difference in the incidence of complications via the two approaches?

    To compare the incidence of complications e.g (bleeding , pseudoaneurysm formation ,e.t.c ) between the right and left radial approaches .

    baseline

  • Comparison between right and left radial approach in patients undergoing percutaneous coronary Procedures regarding the incidence of crossover between right and left radial approaches and between radial and femoral approach .

    To compare the incidence of crossover between right and left radial arteries and femoral approach in case of marked radial spasm .

    baseline

Study Arms (2)

Right Radial Group

Other: Coronary angiography and percutaneous coronary intervention

Left Radial Group

Other: Coronary angiography and percutaneous coronary intervention

Interventions

Coronary angiography and percutaneous coronary intervention via radial approach

Left Radial GroupRight Radial Group

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing coronary angiography or elective PCI in assiut university heart hospital.

You may qualify if:

  • All patients presented to assiut university cardiac catheterization laboratory and eligible for radial coronary procedures (either diagnostic or interventional )

You may not qualify if:

  • Patients with acute coronary syndrome.
  • Patients with chronic upper limb ischemia
  • Patients with AV fistula
  • Patients with severe renal impairment
  • Failure to successfully cannulate the radial artery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, Egypt

Location

Related Publications (10)

  • Daralammouri Y, Nazzal Z, Mosleh YS, Abdulhaq HK, Khayyat ZY, Hamshary YE, Azamtta M, Ghanim A, Awwad F, Majadla S, Maree M, Hamaida J, Ismail Y. Distal Radial Artery Access in comparison to Forearm Radial Artery Access for Cardiac Catheterization: A Randomized Controlled Trial (DARFORA Trial). J Interv Cardiol. 2022 Jul 15;2022:7698583. doi: 10.1155/2022/7698583. eCollection 2022.

    PMID: 35911661BACKGROUND
  • Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.

    PMID: 28506941BACKGROUND
  • Lee OH, Roh JW, Im E, Cho DK, Jeong MH, Choi D, Kim Y. Feasibility and Safety of the Left Distal Radial Approach in Percutaneous Coronary Intervention for Bifurcation Lesions. J Clin Med. 2021 May 19;10(10):2204. doi: 10.3390/jcm10102204.

    PMID: 34069701BACKGROUND
  • Klimek K, Swiatek M, Klocek K, Tworek M, Zwolski M, Milewski K, Janas A. Comparison of Safety and Efficiency between Tiger-2 Catheter with Right Radial Artery Access and Judkins Catheter with Left Radial Artery Access. J Clin Med. 2021 Sep 6;10(17):4020. doi: 10.3390/jcm10174020.

    PMID: 34501468BACKGROUND
  • Burzotta F, Trani C, De Vita M, Crea F. A new operative classification of both anatomic vascular variants and physiopathologic conditions affecting transradial cardiovascular procedures. Int J Cardiol. 2010 Nov 5;145(1):120-2. doi: 10.1016/j.ijcard.2009.06.025. Epub 2009 Jul 17.

    PMID: 19616324BACKGROUND
  • Dehghani P, Mohammad A, Bajaj R, Hong T, Suen CM, Sharieff W, Chisholm RJ, Kutryk MJ, Fam NP, Cheema AN. Mechanism and predictors of failed transradial approach for percutaneous coronary interventions. JACC Cardiovasc Interv. 2009 Nov;2(11):1057-64. doi: 10.1016/j.jcin.2009.07.014.

    PMID: 19926044BACKGROUND
  • Kawamura Y, Yoshimachi F, Nakamura N, Yamamoto Y, Kudo T, Ikari Y. Impact of dedicated hemostasis device for distal radial arterial access with an adequate hemostasis protocol on radial arterial observation by ultrasound. Cardiovasc Interv Ther. 2021 Jan;36(1):104-110. doi: 10.1007/s12928-020-00656-4. Epub 2020 Mar 12.

    PMID: 32166728BACKGROUND
  • Abdelazeem B, Abuelazm MT, Swed S, Gamal M, Atef M, Al-Zeftawy MA, Noori MA, Lutz A, Volgman AS. The efficacy of nitroglycerin to prevent radial artery spasm and occlusion during and after transradial catheterization: A systematic review and meta-analysis of randomized controlled trials. Clin Cardiol. 2022 Dec;45(12):1171-1183. doi: 10.1002/clc.23906. Epub 2022 Nov 6.

    PMID: 36335609BACKGROUND
  • Kiemeneij F, Burzotta F, Fajadet J. Thirty years of transradial coronary interventions. EuroIntervention. 2022 May 15;18(1):19-21. doi: 10.4244/EIJ-E-22-00009. No abstract available.

    PMID: 35570688BACKGROUND
  • RADNER S. Thoracal aortography by catheterization from the radial artery; preliminary report of a new technique. Acta Radiol (Stockh). 1948 Feb 28;29(2):178-80. doi: 10.3109/00016924809132437. No abstract available.

    PMID: 18908938BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 25, 2022

Study Start

November 15, 2022

Primary Completion

December 15, 2024

Study Completion

April 15, 2025

Last Updated

June 4, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations