Comparison Between Right and Left Radial Approach in Patients Undergoing Percutaneous Coronary Procedures

Coronary Artery Disease Clinical Trial

Official title:

Comparison Between Right and Left Radial Approach in Patients Undergoing Percutaneous Coronary Procedures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05626660
• Other study ID #: Coronary procedures
• Status: Not yet recruiting
• Start date: November 15, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: Kerillos A Ayoub, Doctor
• Phone: 01001071255
• Email: kyrillosalfy295[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The radial artery has progressively became the standard access site for percutaneous coronary procedures both diagnostic and interventional. The first trans-radial access (TRA) for cardiovascular diagnostics dates to 1947.

In 1989, the first case series of 100 coronary angiographies performed through the radial access, demonstrating the safety and the fast mobilization of patients with the radial approach .

The main advantages of the radial approach are increased safety and comfort of the patients with reduction of bleeding complications and immediate post-procedure ambulation .with these advantages, current guidelines highly recommend radial access for coronary angiography and percutaneous coronary intervention.

Most clinical trials focused solely on the right radial approach (RRA) and rarely consider the left radial approach (LRA). Indeed, the RRA has technical obstacles related to anatomy and clinical practice like increased incidence of tortuosity of the subclavian artery and radial-ulnar artery loop with the RRA Most operators use the right radial access as the left radial access increase operator discomfort during vascular access and procedure, especially in obese patients.

However, the left radial access has potential benefits for both the patient and operator. One of which is that the left radial approach is associated with lower fluoroscopy time compared with the right radial approach.

Left radial artery as well is an appropriate alternative access for coronary catheterization with less anatomical variations like tortuosity than the right radial artery Moreover, left radial access is preferred for right handed patients because of temporary post-procedural disability caused by haemostasis process in right radial artery access Also subclavian artery tortuosity is significantly more common on the right side and is an important cause of difficult, prolonged, or failed radial procedure, Kawashima et al examined 437 patients undergoing diagnostic angiography through the left and right radial approaches. Severe subclavian tortuosity is found in approximately 10% of the right radial access versus none in left radial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: October 31, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• • 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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Other:
• Coronary angiography and percutaneous coronary intervention
Coronary angiography and percutaneous coronary intervention via radial approach

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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