Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients (DONATION)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Coronary Syndrome; Procedural Complication
• Intervention / Treatment: Procedure: distal TRA group; Procedure: conventional TRA group

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Shenzhen People's Hospital
      • Contact: Tangzhiming Li, PhD.; Phone Number: +86 18588269277; Email: litangzhiming@126.com
      • Contact: Xin Sun, PhD.; Phone Number: +86 18126540853; Email: sunxinflying@163.com
      • Principal Investigator: Shaohong Dong, PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• presence of a pulse in the snuffbox

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dTRA group; Investigators perform percutaneous coronary intervention by dTRA	Procedure: distal TRA group; dTRA for PCI procedure to ACS patients.
Other: TRA group; Investigators perform percutaneous coronary intervention by conventional TRA	Procedure: conventional TRA group; Conventional TRA for PCI procedure to ACS patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of One attempt success	Rate of One attempt success of 2 kinds of procedure	during procedure
Access time	Access time of 2 kinds of procedure	during procedure
Procedure time	Procedure time of 2 kinds of procedure	during procedure
Crossover rate	Crossover rate of 2 kinds of procedure	during procedure
Contrast dose	Contrast dose of 2 kinds of procedure	during procedure
Fluoroscopy dose	Fluoroscopy dose of 2 kinds of procedure	during procedure
hand hematoma	hand hematoma rate of 2 kinds of procedure	during procedure
The total cost in hospitalization	Healthcare cost .	up to 2 years

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Major Adverse Cardiovascular Events; Distal Radial Access; Radial Artery Occlusion
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: DONATION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No