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Vascular Closure Device

Perclose with Statseal Device for Cardiovascular Disease

N/A
Waitlist Available
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Delivery of a 14-16 French Transcatheter aortic valve replacement system
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours post procedure (± 1 hour)
Awards & highlights

Study Summary

This trial compares the effectiveness of 2 FDA-approved devices for sealing blood vessels after a heart valve replacement procedure. It may reduce procedure time & complications.

Eligible Conditions
  • Cardiovascular Disease
  • Arterial Blockage
  • Hematoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
A large catheter (14-16 French) will be used to replace the aortic valve.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours post procedure (± 1 hour)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post procedure (± 1 hour) 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
Percent of patients with hematoma

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Perclose with Statseal DeviceExperimental Treatment2 Interventions
Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
Group II: Perclose OnlyActive Control1 Intervention
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Statseal
2023
N/A
~50
Perclose
2023
N/A
~50

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,521 Previous Clinical Trials
10,278,886 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any volunteers able to participate in this clinical research at the present time?

"Affirmative. Clinicaltrials.gov displays that this clinical research, which was first posted on December 1st 2023, is currently enrolling patients. 50 people are required to be accepted from one medical centre."

Answered by AI

To what extent has this experiment been populated with participants?

"Affirmative. Clinicaltrials.gov's records demonstrate that the medical trial, posted on December 1st 2023, is currently in need of participants. The study requires 50 volunteers to be recruited from a single research site."

Answered by AI
~23 spots leftby Mar 2025