Your session is about to expire
← Back to Search
Vascular Closure Device
Statseal vs. Perclose for Cardiovascular Procedures
N/A
Recruiting
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
Patient undergoing diagnostic angiography or PCI with femoral access who undergo PercloseTM closure.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at least 15 minutes after abultation occurs for those in the outpatient setting.
Awards & highlights
Study Summary
This trial is comparing two devices that are used to seal an artery after a transfemoral procedure. It is expected that using both devices will shorten the time it takes to seal the artery, resulting in less time that patients need to lay flat.
Who is the study for?
This trial is for patients undergoing transfemoral procedures with a 6 French system who may need arterial closure. Suitable candidates have used PercloseTM and can consent personally. Exclusions include those using other hemostasis methods, only radial/brachial access, certain anticoagulants or oral anticoagulants during the procedure, deformities preventing device placement, clinical instability like shock or emergent conditions.Check my eligibility
What is being tested?
The study compares two FDA-approved devices—Perclose and Statseal—for sealing arteries after femoral catheterization. It aims to determine if combining these devices reduces the time needed for artery closure compared to using Perclose alone, potentially shortening patient recovery time.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of arterial closure devices might include discomfort at the site of application, bleeding complications such as hematoma formation or delayed bleeding from the puncture site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a heart vessel exam or treatment through my groin and will have a special closure device used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at least 15 minutes after abultation occurs for those in the outpatient setting.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least 15 minutes after abultation occurs for those in the outpatient setting.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Ambulation
Secondary outcome measures
Hematoma
Time to Discharge
Time to hemostasis
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 one minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed 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. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. 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 and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation.
Group II: Perclose OnlyActive Control1 Intervention
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least one 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. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. 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 and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perclose
2023
N/A
~50
Statseal
2023
N/A
~50
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,534 Previous Clinical Trials
10,267,246 Total Patients Enrolled
5 Trials studying Atherosclerosis
176 Patients Enrolled for Atherosclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My catheterization will be through my arm or hand.I have a dialysis fistula in the same leg.I am having a heart vessel exam or treatment through my groin and will have a special closure device used.I cannot give my own consent for the study.I am currently taking blood thinners and will continue during the procedure.I am taking a blood thinner that is not unfractionated heparin or bivalirudin.I am using a blood clotting method or device that is not PercloseTM.I do not have any leg injuries that would interfere with medical band placement.I am planned for a radial approach but can switch to femoral if needed.I have used glycoprotein inhibitors or cangrelor.You have used sheathless guides.I will need blood thinners after my catheter procedure.You have had a medical procedure using a 6Fr catheter.
Research Study Groups:
This trial has the following groups:- Group 1: Perclose Only
- Group 2: Perclose with Statseal Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being assessed in this experiment?
"Affirmative. Clinicaltrials.gov suggests that this clinical study is currently in search of participants, and was first posted on August 1st 2022 with recent updates occuring on the 12th of August 2022. 150 patients are sought for research at two separate sites."
Answered by AI
Is there still capacity for enrolment in this clinical trial?
"Affirmative. Documentation on clinicaltrials.gov illustrates that this experiment, which was initially posted 8/1/2022 is actively seeking participants. 150 individuals are needed from 2 separate medical facilities for the trial's completion."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger