NCT03986151

Brief Summary

This randomized, single-center, prospective study seeks to compare the conventional radial approach with the recently described distal radial approach (anatomical snuffbox) concerning the patency of the radial artery in patients subjected to coronary angiography or percutaneous coronary intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,042

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

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

June 11, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

June 11, 2019

Last Update Submit

March 9, 2021

Conditions

Coronary Artery DiseaseVascular Access Complication

Keywords

coronary angiographyradial accessdistal radial accessanatomical snuffboxradial artery occlusion

Outcome Measures

Primary Outcomes (1)

  • Rate of right radial artery occlusion

    ≥30 days after CAG or PCI

Secondary Outcomes (12)

  • Rate of successful insertion of the sheath

    Immediately post-procedurally

  • Duration of sheath insertion procedure

    Immediately post-procedurally

  • Rate of successful completion of coronary angiography

    Immediately post-procedurally

  • Rate of successful completion of percutaneous coronary intervention

    Immediately post-procedurally

  • Total Contrast volume

    Immediately post-procedurally

  • +7 more secondary outcomes

Study Arms (2)

Conventional radial access

ACTIVE COMPARATOR
Procedure: Coronary angiography +/- percutaneous coronary intervention

Distal radial access

EXPERIMENTAL
Procedure: Coronary angiography +/- percutaneous coronary intervention

Interventions

Coronary angiography +/- percutaneous coronary interventionPROCEDURE

Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)

Conventional radial accessDistal radial access

Eligibility Criteria

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

You may qualify if:

  • Indication for coronary angiography
  • Informed consent

You may not qualify if:

  • Non palpable right radial artery
  • Prior complicated right transradial intervention (radial artery dissection, perforation, occlusion)
  • Prior CABG
  • STEMI
  • Hemodynamic instability
  • Anatomical restrictions (fistula, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

Location

MeSH Terms

Conditions

Coronary Artery DiseaseArterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisVascular Diseases

Study Officials

  • Grigorios Tsigkas, MD, Phd

    University Hospital of Patras

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology consultant

Study Record Dates

First Submitted

June 11, 2019

First Posted

June 14, 2019

Study Start

June 11, 2019

Primary Completion

February 20, 2021

Study Completion

February 20, 2021

Last Updated

March 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Locations

GR(1)