Decrease Artery Occlusion by Distal Radial Arterial Cannulation, Observational Study

NCT05230719 | Unknown DMC

• 1 other identifier: DONATION-OB
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The site of arterial access for coronary angiography and intervention has been the focus of research for decades as it is the source of major complications. Transradial access (TRA) reduces complications among patients undergoing percutaneous coronary procedures but is reported with the complication of radial artery occlusion (RAO) that limits the radial artery for future needs. Distal radial access (dTRA) has recently gained global popularity as an alternative access route for vascular procedures. Among the benefits of dTRA are the low risk of entry site bleeding complications, the low rate of radial artery occlusion, and improved patient and operator comfort. This study aims to reveal the feasibility and safety of dTRA and routine TRA procedures in acute coronary syndrome patients. The primary endpoints are forearm radical occlusion rate and major adverse cardiovascular events (MACEs) in the two groups. Investigators conduct this retrospected analysis to demonstrate the difference of the two procedure of Cannulation.

Conditions

Acute Coronary Syndrome; Procedural Complication; Outcome, Fatal

Keywords

Distal Radial Access; Radial Artery Occlusion; Major Adverse Cardiovascular Events

Outcome Measures

Primary Outcomes (2)

• Forearm radical

  Doppler ultrasound to determine whether patients suffer forearm radial occlusion

  2 years

• MACEs

  Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.

  2 years

Study Arms (2)

dTRA group

Investigators perform percutaneous coronary intervention by dTRA for patients

Procedure: Radial Artery Approach

TRA group

Investigators perform percutaneous coronary intervention by conventional TRA for patients

Procedure: Radial Artery Approach

Interventions

Radial Artery Approach PROCEDURE

dTRA or conventional TRA for radical artery approach

TRA group; dTRA group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients who received coronary angiography, based on arterial cannulation procedure, were divided into two groups, dTRA and conventional TRA. We conduct this study to illustrate the complication and MACEs of these two kinds of access.

You may qualify if:

• presence of a pulse in the snuffbox

You may not qualify if:

• Absence of pulse
• Ultrasound indication of arterial occlusion or severe calcification
• Severe forearm artery malformation
• Patients with severe liver and renal failure, or abnormal coagulation function
• Established cardiogenic shock
• History of previous coronary artery bypass grafting and radial artery use.
• Raynaud's disease in the medical history

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Tangzhiming Li, PhD.

CONTACT

+86 18588269277; litangzhiming@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 9, 2022
• Study Start: January 1, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)