NCT02269722

Brief Summary

The investigators will assess the effect of different times of radial clamp post procedure on radial artery occlusion and bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
564

participants targeted

Target at P50-P75 for phase_3 coronary-artery-disease

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

September 28, 2014

Last Update Submit

October 4, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of radial artery occlusion

    Flow assessed by pulse oximeter

    24 hours

Secondary Outcomes (1)

  • Bleeding

    24 hours

Study Arms (2)

Short Clamp time

EXPERIMENTAL

Radial clamp applied at full pressure for 20 minutes. At the end of 20 minutes, the clamp will be loosened ¼ turn every 5 minutes over 20 minutes and then removed.

Device: Vascular compression device- RADAR TM-Short clamp time

Long Clamp Time

EXPERIMENTAL

Radial clamp applied at full pressure for 60 minutes. At the end of 60 minutes, the clamp is to be loosened and removed under the same instruction as those patients in arm one.

Device: Vascular compression device RADAR TM-Long clamp time

Interventions

A clamp is placed on the radial artery following cardiac catheterization for 20 minutes

Short Clamp time

A clamp is placed on the radial artery following cardiac catheterization for 20 minutes

Long Clamp Time

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who require cardiac catheterization via the radial approach for the investigation and treatment of coronary artery disease.
  • Patients must have evidence of pre-procedural radial artery patency using Barbeau test.
  • Patients must be able to give informed consent

You may not qualify if:

  • Evidence of pre-procedural radial artery thrombosis
  • Inability to give informed consent
  • Patient desire not to participate in the study
  • Emergent procedures when the delay associated for obtaining informed consent may affect patient outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Science Center

London, Ontario, N6A5A5, Canada

Location

Related Publications (1)

  • Lavi S, Cheema A, Yadegari A, Israeli Z, Levi Y, Wall S, Alemayehu M, Parviz Y, Murariu BD, McPherson T, Syed J, Bagur R. Randomized Trial of Compression Duration After Transradial Cardiac Catheterization and Intervention. J Am Heart Assoc. 2017 Feb 3;6(2):e005029. doi: 10.1161/JAHA.116.005029.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Shahar Lavi, MD

    LHSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

September 28, 2014

First Posted

October 21, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 5, 2016

Record last verified: 2016-10

Locations