← Back to Search

Vascular Closure Device

Subjects that receive PerQseal Plus Device for Percutaneous Vascular Closure

N/A
Waitlist Available
Research Sponsored by Vivasure Medical Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Age ≥ 19 years, 2. Clinically indicated for a large bore interventional transcatheter procedure, e.g., transcatheter aortic valve repair (TAVR) or endovascular abdominal aortic aneurysm repair (EVAR), or thoracic endovascular aneurysm repair (TEVAR) using a percutaneous common femoral arteriotomy created by a 14 to 22 F sheath, 3. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements, 4. Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
-
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 minutes
Awards & highlights

Study Summary

The objective of this Early Feasibility Study (EFS) is to evaluate the initial safety and preliminary effectiveness of the PerQseal®+ VCD in a small number of subjects when used to achieve hemostasis of common femoral arteriotomies created by 14 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing Percutaneous Transcatheter procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy: Time to Haemostasis
Safety: Major Access Site Complications
Secondary outcome measures
Efficacy: PerQseal® Device Technical Success Rate
Efficacy: PerQseal® Treatment Success Rate
Efficacy: Time to Ambulation
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects that receive PerQseal Plus DeviceExperimental Treatment1 Intervention
Subjects undergoing large hole endovascular percutaneous procedures with a femoral arteriotomy created with 14 to 22 F sheaths (arteriotomy up to 26 F)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PerQseal Plus Device
2022
N/A
~20

Find a Location

Who is running the clinical trial?

Vivasure Medical LimitedLead Sponsor
10 Previous Clinical Trials
653 Total Patients Enrolled

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
PerQseal®+ Early Feasibility Study
2022. "PerQseal®+ Early Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05163548.
~5 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top