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

Sponsor

Shenzhen People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05255939

Collaborator

(none)

1,500

Enrollment

Location

Arms

23.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Procedural Complication	Procedure: distal TRA group Procedure: conventional TRA group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Forearm radical occlusion [during procedure]
Doppler ultrasound to determine whether patients suffer forearm radial occlusion
MACEs [during procedure]
Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shenzhen People's hospital	Shenzhen	Guangdong	China	518000

Sponsors and Collaborators

Shenzhen People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shenzhen People's Hospital

ClinicalTrials.gov Identifier:

NCT05255939

Other Study ID Numbers:

DONATION

First Posted:

Feb 25, 2022

Last Update Posted:

Feb 25, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shenzhen People's Hospital

Distal Radial Access

Radial Artery Occlusion

Major Adverse Cardiovascular Events

Additional relevant MeSH terms:

Acute Coronary Syndrome

Study Results

No Results Posted as of Feb 25, 2022