Statseal vs. Perclose for Cardiovascular Procedures

Recruiting at 1 trial location

Overseen By David M Tehrani, MD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Glycoprotein inhibitors, Cangrelor

Disqualifiers: Radial approach, Oral anticoagulants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

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. ^{1 2 3 4 5}

Eligibility 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.

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

Treatment Details

Interventions

• Perclose
• Statseal

Trial Overview 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.

Participant Groups

Group I: Perclose with Statseal Device Experimental Treatment 2 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 Only Active Control 1 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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

In an in vitro study comparing four root canal sealers, all sealers significantly reduced apical microleakage compared to a control group using gutta-percha without sealer, indicating their effectiveness in preventing leakage.

Among the sealers tested, Ketac-Endo exhibited significantly more leakage than the zinc oxide-eugenol-based sealers (Tubliseal and Roth's 801), while no significant difference was found between the two formulations of Tubliseal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An in vitro evaluation of microleakage of two new and two old root canal sealers. Smith, MA., Steiman, HR.[2019]

In a study involving 104 single-rooted human teeth, both gutta-percha and Resilon obturation materials showed similar sealing abilities after post space preparation, indicating that either material can be effectively used in dental procedures.

The method of post space preparation, whether using Gates Glidden drills or hand files, did not significantly affect the sealing ability of either gutta-percha or Resilon, suggesting flexibility in technique choice for dental practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of two post-space preparation techniques on the seal of resilon and gutta-percha obturation materials. Ashofteh Yazdi, K., Razmi, H., Ghabraei, S., et al.[2021]

In a study of 42 extracted human teeth, post space preparation showed significant deviation in 19% of cases, with the highest rate (50%) occurring in teeth filled with Thermafil, compared to only 7% in GuttaCore and none in gutta-percha.

The study found that the linear deviation of post space preparation was significantly greater in the Thermafil group, indicating that the type of filling material used can impact the accuracy of post space preparation and the remaining root thickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micro-computed tomography analysis of post space preparation in root canals filled with carrier-based thermoplasticized gutta-percha. Schroeder, AA., Ford, NL., Coil, JM.[2018]

The study found that using mineral trioxide aggregate (MTA) as a root-end filling material can be effectively placed orthograde (before surgery) instead of retrograde (during surgery) in cats' teeth, potentially simplifying the surgical process.

Although there were slightly more instances of hard tissue healing in the orthograde MTA group compared to the retrograde group, the differences were not statistically significant, suggesting that both methods are similarly effective for promoting healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing process following application of set or fresh mineral trioxide aggregate as a root-end filling material. Habibi, M., Ghoddusi, J., Habibi, A., et al.[2021]

In a study of 64 extracted maxillary premolars, the warm vertical condensation technique significantly reduced periapical microleakage compared to the cold lateral condensation technique, regardless of the type of sealer used.

Among the sealers tested, Apexit showed the least microleakage in the cold lateral condensation group, while calcium hydroxide had the highest, indicating that the choice of sealer can impact the effectiveness of the obturation technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Periapical microleakage of root canals filled with four kinds of sealers using two obturation techniques]. Wei, Y., Yan, H., Ma, Q.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

An in vitro evaluation of microleakage of two new and two old root canal sealers. [2019]

2. Iran pubmed.ncbi.nlm.nih.gov

The effect of two post-space preparation techniques on the seal of resilon and gutta-percha obturation materials. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Micro-computed tomography analysis of post space preparation in root canals filled with carrier-based thermoplasticized gutta-percha. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Healing process following application of set or fresh mineral trioxide aggregate as a root-end filling material. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[Periapical microleakage of root canals filled with four kinds of sealers using two obturation techniques]. [2017]