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SoftSeal®-STF hemostatic pad for Angiogram

N/A
Waitlist Available
Led By Muhammad F Jan, MD
Research Sponsored by Aurora Health Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of follow up office visit, if done within 45 days post procedure
Awards & highlights

Study Summary

This trial will test if a new hemostatic pad can help stop bleeding faster than the current standard pad when used with a compression device after a radial transcatheter procedure.

Eligible Conditions
  • Angiogram
  • Percutaneous Coronary Intervention

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of follow up office visit, if done within 45 days post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of follow up office visit, if done within 45 days post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Hemostasis
Secondary outcome measures
Number of Participants Who Completed Patient Satisfaction Assessment
Number of Participants Who Had a Readmission
Number of Participants With Bruising, Swelling, or Redness
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: SoftSeal®-STF hemostaticExperimental Treatment1 Intervention
Hemostasis at the radial access site for subjects randomized to the SoftSeal®-STF hemostatic pad will be obtained by applying pressure at the point proximal and distal to the puncture site and removing the sheath. While still maintaining pressure, the SoftSeal®-STF hemostatic pad will be applied over the puncture site. The cath lab staff will allow a small amount of blood (< 0.2 mL) to contact the surface of the hemostatic pad and then will apply constant pressure.
Group II: RadAR EasyCLik plus SoftSeal®-STF hemostatic padExperimental Treatment1 Intervention
Hemostasis will be obtained with the SoftSeal®-STF hemostatic pad and vascular compression device by applying pressure at the point proximal and distal to the puncture site and removing the sheath. While still maintaining pressure, the SoftSeal®-STF hemostatic pad will be applied over the puncture site. The cath lab staff will allow a small amount of blood (< 0.2 mL) to contact the surface of the hemostatic pad and then will apply constant pressure with a vascular compression device.
Group III: TR BAND® plus SoftSeal®-STF hemostatic padActive Control1 Intervention
Hemostasis will be obtained with the SoftSeal®-STF hemostatic pad and vascular compression device by applying pressure at the point proximal and distal to the puncture site and removing the sheath. While still maintaining pressure, the SoftSeal®-STF hemostatic pad will be applied over the puncture site. The cath lab staff will allow a small amount of blood (< 0.2 mL) to contact the surface of the hemostatic pad and then will apply constant pressure with a vascular compression device.
Group IV: VascBand™ HemostatActive Control1 Intervention
Hemostasis at the radial access for subjects randomized to the VascBand™ Hemostat will be obtained in accordance to the manufacturer's instructions. The VascBand™ device will be placed proximal to the puncture site and inflated slowly while simultaneously removing the sheath, and continue to inject air (max. 18 mL) into the device until hemostasis is obtained.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SoftSeal®-STF hemostatic pad
2018
N/A
~300
RadAR EasyCLik plus ®-STF hemostatic pad
2018
N/A
~300

Find a Location

Who is running the clinical trial?

Aurora Health CareLead Sponsor
43 Previous Clinical Trials
15,885 Total Patients Enrolled
Chitogen, Inc.INDIV
1 Previous Clinical Trials
51 Total Patients Enrolled
Muhammad F Jan, MDPrincipal InvestigatorAurora Health Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
RAVE: Radial Artery Vascular Complication and Resource Utilization
2018. "RAVE: Radial Artery Vascular Complication and Resource Utilization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03522077.
~43 spots leftby Apr 2025
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