NCT04232488

Brief Summary

The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions. This study will compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

January 14, 2020

Last Update Submit

January 15, 2020

Conditions

Keywords

coronary diseasesnuff boxradial access

Outcome Measures

Primary Outcomes (1)

  • Occlusion of the radial artery

    Occlusion of the radial artery used for coronary intervention diagnosed using Color Doppler

    3 months

Study Arms (2)

Angiography performed using distal radial artery

EXPERIMENTAL

Patients undergoing coronary angiography with or without intervention using distal radial artery ('snuff box') as a vascular access

Procedure: coronary angiography using distal radial artery

Angiography performed using proximal radial artery

ACTIVE COMPARATOR

Patients undergoing coronary angiography with or without intervention using proximal radial artery as a vascular access

Procedure: coronary angiography using proximal radial artery

Interventions

Patients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using distal radial artery ('snuff box'); color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery

Angiography performed using distal radial artery

Patients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using proximal radial artery; color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery

Angiography performed using proximal radial artery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed a performed consent, older than 18 YO, clear indication for coronary angiography, palpable radial pulse

You may not qualify if:

  • hemodynamic instability, critically ill patient, usual coronary angiography contraindication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary DiseaseVascular Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular Diseases

Central Study Contacts

Nikola Pavlović, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Hospital

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

February 1, 2020

Primary Completion

December 31, 2020

Study Completion

February 1, 2021

Last Updated

January 18, 2020

Record last verified: 2020-01