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

NCT04784078 | Unknown DMC

• 1 other identifier: DC radial
• Study Type: interventional
• Target: 938
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Disease

Keywords

Distal radial artery; Radial access

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

dTRA group

EXPERIMENTAL

Procedure: Coronary Angiography and Intervention

cTRA group

ACTIVE COMPARATOR

Procedure: Coronary Angiography and Intervention

Interventions

Coronary Angiography and Intervention PROCEDURE

Transradial access puncture site

cTRA group; dTRA group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Related Publications (5)

• 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. No abstract available.

  PMID: 32553614 BACKGROUND

• 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.

  PMID: 31227393 RESULT

• 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.jcin.2018.04.045.

  PMID: 30336816 RESULT

• 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):678-680. doi: 10.1016/j.carrev.2018.09.018. Epub 2018 Oct 2.

  PMID: 30314833 RESULT

• 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. No abstract available.

  PMID: 31675155 RESULT

MeSH Terms

Conditions

Coronary Disease

Interventions

Methods

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Yujie Zhou, Doctor

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Lixia Yang, Doctor

CONTACT

13661339066; ylx966@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: April 10, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share