NCT04163471

Brief Summary

VasoStat vs. TR Band compression for Radial Artery Hemostasis Following Transradial Catheterization Without Prior Radial Artery Access

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

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

June 4, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

August 22, 2018

Last Update Submit

November 12, 2019

Conditions

Coronary Artery DiseasePeripheral Arterial Disease

Keywords

VasoStatTR BandTransradial accessCoronary angiographyPeripheral arterial diseaseCoronary artery diseasePeripheral angiographyStents

Outcome Measures

Primary Outcomes (1)

  • Comparison of impact of two radial artery compression devices on hand perfusion measurements

    Changes in Hand perfusion will be quantified using a noninvasive pulse oximetry technique and a previously validated metric known as the Perfusion Index, which is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. The Perfusion Index represents a noninvasive measure of hand perfusion that can be continuously and noninvasively obtained from a specialized pulse oximeter.

    Perfusion index measurements day 1: before radial artery puncture, during wrist compression, after removal of compression device. Final perfusion index at 30-day followup appointment.

Secondary Outcomes (3)

  • Comparison of impact of two radial artery compression devices on hand perfusion prior to and during ulnar artery compression

    Perfusion index measurements on day 1 with ulnar compression: will include before radial artery puncture, and during wrist compression after radial sheath removal.

  • Patient satisfaction during use of wrist compression device

    During application of radial artery mechanical compression

  • Hand perfusion and radial artery patency after one month

    30 day follow-up after use of mechanical wrist compression following transradial access for arterial catheterization procedures

Other Outcomes (1)

  • Adverse outcomes

    During index hospital visit and at 30 day follow-up

Study Arms (2)

VasoStat

Randomized to use of VasoStat radial mechanical compression for hemostasis device following sheath removal after transradial access for arterial catheterization procedures.

Device: Radial artery mechanical compression for hemostasis

TR Band

Randomized to use of TR Band radial mechanical compression for hemostasis device following sheath removal after transradial access for arterial catheterization procedures.

Device: Radial artery mechanical compression for hemostasis

Interventions

Radial artery mechanical compression for hemostasisDEVICE

Transradial hemostasis following arterial catheterization procedures

TR BandVasoStat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referred for diagnostic or interventional arterial catheterization procedures who have coronary artery disease or peripheral artery disease

You may qualify if:

  • no prior radial access

You may not qualify if:

  • Patients receiving concurrent investigational medications
  • Cellulitis overlying radial artery
  • Oral anticoagulation
  • Patients receiving glycoprotein IIb/IIIa inhibitors
  • Dementia
  • Prisoners
  • Institutionalized individuals
  • Allergy to medical adhesive
  • Radial sheath \> 6 French (ID)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Billings Clinic Heart and Vascular at Community Medical Center

Missoula, Montana, 59804, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseasePeripheral Arterial Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAtherosclerosisPeripheral Vascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2018

First Posted

November 14, 2019

Study Start

June 4, 2018

Primary Completion

March 6, 2019

Study Completion

May 1, 2019

Last Updated

November 14, 2019

Record last verified: 2019-11

Locations

US(1)