NCT02711514

Brief Summary

Comparison of Crossover rates of Radial Cardiac Catheterizations and/or PCIs into femoral vs published literature

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

5.6 years

First QC Date

March 14, 2016

Last Update Submit

February 18, 2021

Conditions

Retrospective Review

Outcome Measures

Primary Outcomes (1)

  • Crossover rate from Radial to Femoral access

    How often do you start a Cath on the Radial Artery and for any reason, have to switch to Femoral Artery.

    1 year

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1000 Consecutive Patients who underwent Radial (or Ulnar) Artery Procedures in the Cardiac Cath Lab for Diagnostic Cardiac Catheterizations and/or Percutaneous Coronary Interventions.

You may qualify if:

  • Patients coming to the emergency room requiring Diagnostic Cardiac Catheterizations and/or Percutaneous Coronary Interventions

You may not qualify if:

  • Cardiac Tamponade
  • Cardiogenic Shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Study Officials

  • Ramon Quesada, MD

    Director Structural Heart BHSF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Cardiac and Vascular Institute

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 17, 2016

Study Start

December 1, 2014

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

US(1)