NCT02873871

Brief Summary

Randomized clinical trial to compare radial artery patency after transradial coronary catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or therapeutic coronary catheterization will be prospectively enrolled in this single-center trial and will be randomized to radial hemostasis with TerumoBand® or a standardized compressive dressing with gauze and elastic bandage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

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

August 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

2.3 years

First QC Date

April 10, 2016

Last Update Submit

August 10, 2020

Conditions

Coronary Artery Disease With Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Radial artery occlusion evaluated using Barbeau's test

    test immediately after hemostasis compression device withdrawal

    up to 3 hours

Secondary Outcomes (2)

  • Vascular complications

    up to 3 hours

  • Radial access site pain

    up to 3 hours

Study Arms (2)

Control group

OTHER

Standardized compressive dressing

Device: Standardized compressive dressing

Intervention group

EXPERIMENTAL

Hemostasis with TerumoBand®

Device: Hemostasis with TerumoBand®

Interventions

Standardized compressive dressingDEVICE

Standardized compressive dressing

Control group
Hemostasis with TerumoBand®DEVICE

Hemostasis with TerumoBand®

Intervention group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients submitted to elective or urgent coronary catheterization who presented with a A, B or C curve on oximetry test before the procedure

You may not qualify if:

  • Inability to understand the study and sign the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Sul - Post Graduated Program

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease, Autosomal Dominant, 1

Study Officials

  • Eneida Rejane Rabelo da Silva, RN, MSc, ScD

    Hospital de Clinicas de Porto Alegre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2016

First Posted

August 22, 2016

Study Start

August 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations

BR(1)