DONATION-OB: Decrease Artery Occlusion by Distal Radial Arterial Cannulation, Observational Study

Sponsor
Shenzhen People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05230719
Collaborator
(none)
2,000
1
60
33.3

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. Investigators conduct this retrospected analysis to demonstrate the difference of the two procedure of Cannulation.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radial Artery Approach

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Decrease Artery Occlusion by Distal Radial Arterial Cannulation, Observational Study
Actual Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
dTRA group

Investigators perform percutaneous coronary intervention by dTRA for patients

Procedure: Radial Artery Approach
dTRA or conventional TRA for radical artery approach

TRA group

Investigators perform percutaneous coronary intervention by conventional TRA for patients

Procedure: Radial Artery Approach
dTRA or conventional TRA for radical artery approach

Outcome Measures

Primary Outcome Measures

  1. Forearm radical [2 years]

    Doppler ultrasound to determine whether patients suffer forearm radial occlusion

  2. MACEs [2 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
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:
NCT05230719
Other Study ID Numbers:
  • DONATION-OB
First Posted:
Feb 9, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shenzhen People's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022