Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention

Coronary Disease Clinical Trial

Official title:

Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04784078
• Other study ID #: DC radial
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2021
• Source: Beijing Anzhen Hospital
• Contact: Lixia Yang, Doctor
• Phone: 13661339066
• Email: ylx966[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Distal radial access (dTRA) represents a novel site for radial artery access in interventional cardiology, there is little data compare dTRA with conventional radial access (cTRA) in a randomized manner.

It aims to randomly compare between the new distal radial access via the snuffbox and the conventional radial access for percutaneous coronary intervention (PCI) and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time.

Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours before and after the procedure, 4 weeks after procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 938
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patient is over 18 years of age.

• Patient is undergoing diagnostic coronary angiography and/or PCI for the first time.

• Patient has provided written informed consent.

• Patient is willing to comply with all protocol-required evaluations during the hospitalization.

Exclusion Criteria:

• No palpable radial artery or distal radial artery.

• Radial artery used as a bridging vessel.

• Severe heart failure (NYHA class IV).

• Severe renal insufficiency ( SCr>443umol/L).

• Height over 185 cm.

• A =7F catheter may be required for operation.

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Procedure:
• Coronary Angiography and Intervention
Transradial access puncture site

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

References & Publications (5)

Koutouzis M, Kontopodis E, Tassopoulos A, Tsiafoutis I, Katsanou K, Rigatou A, Didagelos M, Andreou K, Lazaris E, Oikonomidis N, Maniotis C, Ziakas A. Distal Versus Traditional Radial Approach for Coronary Angiography. Cardiovasc Revasc Med. 2019 Aug;20(8 — View Citation

Liontou C, Kontopodis E, Oikonomidis N, Maniotis C, Tassopoulos A, Tsiafoutis I, Lazaris E, Koutouzis M. Distal Radial Access: A Review Article. Cardiovasc Revasc Med. 2020 Mar;21(3):412-416. doi: 10.1016/j.carrev.2019.06.003. Epub 2019 Jun 8. Review. — View Citation

Nikolakopoulos I, Vemmou E, Brilakis ES. Distal radial access for cardiac catheterization: When and how. Hellenic J Cardiol. 2020 Mar - Apr;61(2):110-111. doi: 10.1016/j.hjc.2020.06.001. Epub 2020 Jun 14. — View Citation

Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-2119. doi: 10.1016/j. — View Citation

Xenogiannis I, Brilakis ES. Distal radial access at the anatomic snuffbox: The new standard for left radial access? Catheter Cardiovasc Interv. 2019 Nov 1;94(5):658-659. doi: 10.1002/ccd.28551. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion	Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. Incidence of radial artery occlusion as confirmed by absense of antegrade flow in vascular doppler ultrasound.	Within 24 hours after the procedure.