Statseal vs. Perclose for Cardiovascular Procedures
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Must not be taking: Glycoprotein inhibitors, Cangrelor
Disqualifiers: Radial approach, Oral anticoagulants, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transfemoral procedures with 6 French Access. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that patients would need to lay flat.
Will I have to stop taking my current medications?
The trial requires that you do not use certain medications, such as anticoagulants other than unfractionated heparin or bivalirudin, glycoprotein inhibitors, cangrelor, or any oral anticoagulants during the procedure. If you are on these medications, you may need to stop taking them to participate.
What makes the Perclose treatment unique for cardiovascular procedures?
Perclose is a unique treatment for cardiovascular procedures because it uses a suture-mediated closure system to seal the puncture site in the artery after procedures like angiography, which can reduce the time needed for recovery compared to traditional manual compression methods.
12345Eligibility Criteria
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.Inclusion Criteria
I am having a heart vessel exam or treatment through my groin and will have a special closure device used.
I am planned for a radial approach but can switch to femoral if needed.
You have had a medical procedure using a 6Fr catheter.
Exclusion Criteria
My catheterization will be through my arm or hand.
I have a dialysis fistula in the same leg.
I cannot give my own consent for the study.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo transfemoral catheterization with either Perclose alone or Perclose with Statseal device for hemostasis
1 day
1 visit (in-person)
Post-procedure Monitoring
Participants are monitored for time to ambulation and any additional bleeding post-procedure
24 hours
In-patient monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of hematoma presence
24 hours
Participant Groups
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.
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.
Perclose is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Perclose ProGlide for:
- Closure of femoral arterial puncture sites following diagnostic and interventional procedures
🇪🇺 Approved in European Union as Perclose ProGlide for:
- Closure of femoral arterial puncture sites following diagnostic and interventional procedures
🇨🇦 Approved in Canada as Perclose ProGlide for:
- Closure of femoral arterial puncture sites following diagnostic and interventional procedures
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLA Ronald ReagenLos Angeles, CA
UCLA Santa MonicaLos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
References
An in vitro evaluation of microleakage of two new and two old root canal sealers. [2019]An in vitro comparison of apical microleakage of four root canal sealers was performed using a dye leakage/clearing method. Ketac-Endo, Tubliseal (old formula), Tubliseal (new formula), and Roth's 801 cement were compared with a control group of teeth obturated with laterally condensed gutta-percha and no sealer. Teeth were instrumented, obturated, demineralized, and cleared. Linear dye penetration was determined by dissecting microscope. Results were analyzed statistically. All groups obturated with sealer displayed significantly less leakage than the control group. There was no difference between the Tubliseal formulations, and the Ketac-Endo showed significantly more leakage than the three zinc oxide-eugenol-based sealers.
The effect of two post-space preparation techniques on the seal of resilon and gutta-percha obturation materials. [2021]The aim of this study was to compare the effect of post space preparation with Gates Glidden drills or hand files on the sealing ability of gutta-percha or Resilon obturation materials.
Micro-computed tomography analysis of post space preparation in root canals filled with carrier-based thermoplasticized gutta-percha. [2018]To determine whether post space preparation deviated from the root canal preparation in canals filled with Thermafil, GuttaCore or warm vertically compacted gutta-percha.
Healing process following application of set or fresh mineral trioxide aggregate as a root-end filling material. [2021]An unsuccessful attempt to reach the apical area or to place the retrograde material is a major difficulty in periradicular surgery. The aim of this study was to compare the histological evaluation of the healing process following an orthograde versus a retrograde application of mineral trioxide aggregate (MTA) as a root-end filling material during apical surgery on cats' teeth in order to find out whether orthograde placement of MTA before surgery can be used instead of retrograde placement during surgery.
[Periapical microleakage of root canals filled with four kinds of sealers using two obturation techniques]. [2017]To study the periapical microleakage of the root canals filled with four kinds of sealers using two obturation techniques.