NCT03389503

Brief Summary

This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
322

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable coronary-artery-disease

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

Study Start

First participant enrolled

March 8, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

December 27, 2017

Last Update Submit

December 27, 2017

Conditions

Coronary Artery DiseaseStable AnginaUnstable AnginaNon-ST Elevation Myocardial InfarctionST-segment Elevation Myocardial InfarctionIschemic Heart Disease Without Angina

Keywords

Access siteTransradial accessCoronary artery diseaseLearning curve

Outcome Measures

Primary Outcomes (1)

  • Procedural success

    Finishing coronary angiography/intervention without changing approach site

    At the end of procedure

Secondary Outcomes (10)

  • Puncture time

    At the end of procedure

  • Coronary angiography time

    At the end of procedure

  • Puncture + Coronary angiography time

    At the end of procedure

  • Coronary intervention time

    At the end of procedure

  • Contrast amount during coronary angiography

    At the end of procedure

  • +5 more secondary outcomes

Study Arms (2)

Right radial approach

ACTIVE COMPARATOR

Right radial approach for coronary angiography and coronary intervention

Procedure: Radial approach

Left radial approach

ACTIVE COMPARATOR

Left radial approach for coronary angiography and coronary intervention

Procedure: Radial approach

Interventions

Radial approachPROCEDURE

Approach site for coronary angiography and coronary intervention

Left radial approachRight radial approach

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects undergoing coronary angiography via radial approach
  • Subjects undergoing coronary intervention via radial approach
  • Subjects give written informed consent

You may not qualify if:

  • Subjects undergoing procedure(s) other than coronary angiography or intervention
  • Subjects with contraindication of radial approach (i.e, non-palpable radial pulsation, abnormal Allen's test, known radial artery tortuosity or occlusion, arteriovenous fistula for dialysis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAngina, StableAngina, UnstableNon-ST Elevated Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial InfarctionInfarctionIschemiaPathologic ProcessesNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: 1\~3 months: Right radial approach 4\~6 months: Left radial approach
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 27, 2017

First Posted

January 3, 2018

Study Start

March 8, 2017

Primary Completion

September 7, 2017

Study Completion

September 7, 2017

Last Updated

January 3, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)