NCT03522077 is a NA clinical trial of RadAR EasyCLik plus ®-STF hemostatic pad in Angiogram, sponsored by Wake Forest University Health Sciences.

Who is sponsoring NCT03522077?

NCT03522077 is sponsored by Wake Forest University Health Sciences.

What drugs are being tested in NCT03522077?

Interventions in NCT03522077: RadAR EasyCLik plus ®-STF hemostatic pad, TR BAND® Compression device plus ®-STF hemostatic pad, SoftSeal®-STF hemostatic pad, VascBand™ Hemostat.

What condition does NCT03522077 study?

NCT03522077 studies Angiogram, Percutaneous Coronary Intervention.

Is NCT03522077 still recruiting?

NCT03522077 is currently completed. Last updated 3 October 2024.

Are results published for NCT03522077?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-03 · How we verify

NCT03522077

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

RAVE: Radial Artery Vascular Complication and Resource Utilization

Completed NA Results posted Last updated 3 October 2024

What this trial tests

NA trial testing RadAR EasyCLik plus ®-STF hemostatic pad in Angiogram in 300 participants. Completed in 1 December 2021.

Timeline

9 May 2018

Primary endpoint
1 December 2021

1 December 2021

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	9 May 2018
Primary completion	1 December 2021
Estimated completion	1 December 2021
Sites	1 location across United States

Drugs / interventions tested

RadAR EasyCLik plus ®-STF hemostatic pad
TR BAND® Compression device plus ®-STF hemostatic pad
SoftSeal®-STF hemostatic pad
VascBand™ Hemostat

Conditions studied

Angiogram — all drugs for Angiogram →
Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Angiogram or Percutaneous Coronary Intervention. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Hemostasis Primary · 1 day

Time interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis

Group	Value	95% CI
SoftSeal®-STF Hemostatic	19	15 – 30
VascBand™ Hemostat	120	120 – 124
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	44	40 – 58.5
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	45	40 – 69

Number of Participants With Major Access Site Bleeding Secondary · Post procedure to prior to discharge, on average same day discharge or up to 1-2 days

A ≥ 3 mg/dL drop in hemoglobin, or required blood transfusion or vascular repair to control bleeding. Prior to discharge.

Group	Value	95% CI
SoftSeal®-STF Hemostatic	0
VascBand™ Hemostat	0
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	0
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	0

Number of Participants With Minor Access Site Bleeding Secondary · Post procedure to prior to discharge, on average same day discharge or up to 1-2 days

Number of participants with light access site bleeding without hematoma formation

Group	Value	95% CI
SoftSeal®-STF Hemostatic	4
VascBand™ Hemostat	1
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	12
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	20

Number of Participants With Minor Access Site Bleeding Secondary · At time of follow up office visit, if done within 45 days post procedure

Number of participants with light access site bleeding without hematoma formation

Group	Value	95% CI
SoftSeal®-STF Hemostatic	0
VascBand™ Hemostat	0
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	0
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	0

Number of Participants With Hematoma Formation Secondary · 1 day

Number of participants with hematoma formation ≥ 3 cm in diameter

Group	Value	95% CI
SoftSeal®-STF Hemostatic	4
VascBand™ Hemostat	0
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	2
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	5

Visual Analogue Scale (VAS) Secondary · 3 day

Pain at access site on numeric scale of 0-10, 0 meaning no pain at all and 10 meaning extreme pain. A lower score is a better outcome and higher score is a worse outcome.

Group	Value	95% CI
SoftSeal®-STF Hemostatic	0.94	± 1.80
VascBand™ Hemostat	0.51	± 1.29
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	0.38	± 1.31
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	0.42	± 1.27

Visual Analogue Scale (VAS) Secondary · At time of follow up office visit, if done within 45 days post procedure

Pain at access site on numeric scale of 0-10, 0 meaning no pain at all and 10 meaning extreme pain. A lower score is a better outcome and higher score is a worse outcome.

Group	Value	95% CI
SoftSeal®-STF Hemostatic	0.09	± 0.35
VascBand™ Hemostat	0	± 0
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	0	± 0
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	0.03	± 0.22

Number of Participants With Evidence of Hand/Digit Ischemia Secondary · 3 days

Reported as pain, tingling, or numbness in the hand and/or fingers reported

Group	Value	95% CI
SoftSeal®-STF Hemostatic	2
VascBand™ Hemostat	0
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	0
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	0

Number of Participants With Evidence of Hand/Digit Ischemia Secondary · 30 days

Reported as pain, tingling, or numbness in the hand and/or fingers reported

Group	Value	95% CI
SoftSeal®-STF Hemostatic	0
VascBand™ Hemostat	0
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	0
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	0

Number of Participants Who Had a Readmission Secondary · 30 days

Number of Participants who had a Readmission for a Vascular complication

Group	Value	95% CI
SoftSeal®-STF Hemostatic	0
VascBand™ Hemostat	0
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	0
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	0

Number of Participants With Bruising, Swelling, or Redness Secondary · 30 days

Number of participants with bruising, swelling, or redness at or near access site

Group	Value	95% CI
SoftSeal®-STF Hemostatic	5
VascBand™ Hemostat	3
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	5
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	6

Number of Participants Who Completed Patient Satisfaction Assessment Secondary · At time of follow up office visit, if done within 45 days post procedure

Reported as average, above average, or excellent satisfaction with procedure

Group	Value	95% CI
SoftSeal®-STF Hemostatic	3
VascBand™ Hemostat	1
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	4
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	4
SoftSeal®-STF Hemostatic	9
VascBand™ Hemostat	6
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	34
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	20
SoftSeal®-STF Hemostatic	33
VascBand™ Hemostat	41
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	60
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	76
SoftSeal®-STF Hemostatic	4
VascBand™ Hemostat	3
RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad	2
TR BAND® Plus SoftSeal®-STF Hemostatic Pad	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Post procedure (considered time after procedure and prior to discharge), discharge (considered at time of discharge), 3 day follow up, and 30-45 day follow up office visit. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SoftSeal®-STF Hemostatic

Serious: 0/49 (0%)

Deaths: 0/49

VascBand™ Hemostat

Serious: 0/51 (0%)

Deaths: 0/51

RadAR EasyCLik Plus SoftSeal®-STF Hemostatic Pad

Serious: 0/100 (0%)

Deaths: 0/100

TR BAND® Plus SoftSeal®-STF Hemostatic Pad

Serious: 2/100 (2%)

Deaths: 0/100

Serious adverse events (2 terms)

Reaction	System	SoftSeal®-STF Hemostatic	VascBand™ Hemostat	RadAR EasyCLik Plus SoftSe…	TR BAND® Plus SoftSeal®-ST…
acute frontal intraparenchymal hemorrhage.	Vascular disorders	—	—	—	—
Hematoma causing hospitalization	Skin and subcutaneous tissue disorders	—	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	SoftSeal®-STF Hemostatic	VascBand™ Hemostat	RadAR EasyCLik Plus SoftSe…	TR BAND® Plus SoftSeal®-ST…
Minor Bleeding	Surgical and medical procedures	—	—	—	—
Hematoma	Surgical and medical procedures	—	—	—	—

Most-reported serious reactions: acute frontal intraparenchymal hemorrhage., Hematoma causing hospitalization.

Data from ClinicalTrials.gov NCT03522077 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Application and outlook of topical hemostatic materials: a narrative review.
Zhong Y, Hu H, Min N, Wei Y, et al · · 2021 · cited 71× · PMID 33987275 · DOI 10.21037/atm-20-7160
Artificial Scaffolds in Cardiac Tissue Engineering.
Roacho-Pérez JA, Garza-Treviño EN, Moncada-Saucedo NK, Carriquiry-Chequer PA, et al · · 2022 · cited 44× · PMID 35892919 · DOI 10.3390/life12081117

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03522077 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 3 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03522077.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing