Femoral Artery Crossover Rates in 1000 Consecutive Radial... | NCT02711514

Studies
Femoral Artery Crossover Rates in 1000 Consecutive Radial Cath Labs Procedures.

NCT02711514

Sponsor

Miami Cardiac and Vascular Institute

Status

Terminated

Last Update Posted

Feb 21, 2021Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Retrospective Review

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID-19

Expanded Access Info

Start Date

Dec 2014Actual

Primary Completion Date

Jul 2020Actual

Completion Date

Jul 2020Actual

First Submitted Date

Mar 14, 2016

First Submission Date that Met QC Criteria

Mar 14, 2016

First Posted Date

Mar 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2021

Last Update Posted Date

Feb 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Raul Herrera, MD, Director Cardiac and Vascular Institute, Miami Cardiac and Vascular InstitutePrincipal Investigator

Lead Sponsor

Miami Cardiac and Vascular InstituteOTHER

Collaborators

Not provided

Description Module

Brief Summary

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

Detailed Description

A retrospective review of 1000 consecutive Radial or Ulnar Cardiac Catheterizations and/or Percutaneous Coronary Interventions performed in our Institute by one single operator could provide us with the cross over rates to femoral interventions. In this manner these rates could be compared to the published rates of other institutions benchmarking our techniques with the outcomes for such interventions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Cardiac Tamponade
Cardiogenic Shock

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ramon Quesada, MD	Director Structural Heart BHSF	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Miami Cardiac and Vascular Institute		Miami	Florida	33176	United States