N/A N=300 Randomized Treatment

RAVE: Radial Artery Vascular Complication and Resource Utilization

Angiogram · Percutaneous Coronary Intervention

Bottom Line

View on ClinicalTrials.gov: NCT03522077 ↗

Enrolled (actual)

300

Serious AEs

0.7%

Results posted

Feb 2023

Primary outcome: Primary: Time to Hemostasis — 19; 120; 44; 45 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: RadAR EasyCLik plus ®-STF hemostatic pad (Device); TR BAND® Compression device plus ®-STF hemostatic pad (Device); SoftSeal®-STF hemostatic pad (Device); VascBand™ Hemostat (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Hemostasis	19; 120; 44; 45	—
SECONDARY Number of Participants With Major Access Site Bleeding	0; 0; 0; 0	—
SECONDARY Number of Participants With Minor Access Site Bleeding	0; 0; 0; 0	—
SECONDARY Number of Participants With Minor Access Site Bleeding	0; 0; 0; 0	—
SECONDARY Number of Participants With Hematoma Formation	4; 0; 2; 5	—
SECONDARY Visual Analogue Scale (VAS)	0.09; 0; 0; 0.03	—
SECONDARY Visual Analogue Scale (VAS)	0.09; 0; 0; 0.03	—
SECONDARY Number of Participants With Evidence of Hand/Digit Ischemia	0; 0; 0; 0	—
SECONDARY Number of Participants With Evidence of Hand/Digit Ischemia	0; 0; 0; 0	—
SECONDARY Number of Participants Who Had a Readmission	0; 0; 0; 0	—
SECONDARY Number of Participants With Bruising, Swelling, or Redness	5; 3; 5; 6	—
SECONDARY Number of Participants Who Completed Patient Satisfaction Assessment	3; 1; 4; 4; 9; 6	—
SECONDARY Number of Participants With Level of Post Procedure Healing	4; 2; 4; 4; 6; 5	—

Summary

The primary objective of this study is to determine if there is a reduction in time to hemostasis in subjects treated with SoftSeal®-STF hemostatic pad when used in conjunction with a vascular compression device after radial transcatheter procedure.

Eligibility Criteria

Inclusion Criteria

Scheduled for an angiogram/PCI
Planned transradial approach

Exclusion Criteria

Evidence of impaired dual perfusion to the hand when tested using Allen's test
Inaccessible radial arteries due to anatomic variations
Infection or other skin disorder at the puncture site
Undergoing an emergent or unplanned angiogram using the transradial approach
Evidence of severe cognitive impairment or inability to understand the study procedures and answer follow-up questions
Known sensitivity or allergic reaction to materials in the study devices
Unwilling to participate in the study and follow all study-related procedures
Participating physician deems the subject to not be a good candidate
Inability to achieve radial access

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03522077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.