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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

Must not have

Patients undergoing catheterization only from the radial, brachial, ulnar, or distal radial (snuffbox) artery approach.

Presence of arteriovenous dialysis fistula in the ipsilateral leg.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at least 15 minutes after abultation occurs for those in the outpatient setting.

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am having a heart vessel exam or treatment through my groin and will have a special closure device used.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My catheterization will be through my arm or hand.

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I have a dialysis fistula in the same leg.

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I cannot give my own consent for the study.

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I am currently taking blood thinners and will continue during the procedure.

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I am taking a blood thinner that is not unfractionated heparin or bivalirudin.

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I do not have any leg injuries that would interfere with medical band placement.

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I have used glycoprotein inhibitors or cangrelor.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at least 15 minutes after abultation occurs for those in the outpatient setting. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Ambulation

Secondary study objectives

Hematoma

Time to Discharge

Time to hemostasis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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