Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients

NCT05255939 | Unknown DMC

• 1 other identifier: DONATION
• Study Type: interventional
• Target: 1,500
• 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, respectively. Investigators will also focus on puncture success in diagnostic and interventional cases, rate of One attempt success, access time, procedure time, crossover rate, contrast dose of patients, fluoroscopy time and dose, and healthcare cost of each group.

Conditions

Acute Coronary Syndrome; Procedural Complication

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Forearm radical occlusion

  Doppler ultrasound to determine whether patients suffer forearm radial occlusion

  during procedure

• MACEs

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

  during procedure

Secondary Outcomes (8)

• Rate of One attempt success

  during procedure

• Access time

  during procedure

• Procedure time

  during procedure

• Crossover rate

  during procedure

• Contrast dose

  during procedure

Study Arms (2)

dTRA group

EXPERIMENTAL

Investigators perform percutaneous coronary intervention by dTRA

Procedure: distal TRA group

TRA group

OTHER

Investigators perform percutaneous coronary intervention by conventional TRA

Procedure: conventional TRA group

Interventions

distal TRA group PROCEDURE

dTRA for PCI procedure to ACS patients.

dTRA group

conventional TRA group PROCEDURE

Conventional TRA for PCI procedure to ACS patients

TRA group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 25, 2022
• Study Start: March 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)