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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two devices, Perclose alone and Perclose with Statseal, in stopping bleeding after certain heart-related procedures. The goal is to speed up recovery by reducing the time patients must lie flat post-procedure. Patients undergoing a heart procedure through the thigh with a 6 French catheter, where Perclose is used, may qualify for this trial. As an unphased trial, this study provides an opportunity to contribute to innovative research that could improve recovery experiences for future patients.

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 prior data suggests that these devices are safe for cardiovascular procedures?

Research has shown that both the Perclose and Statseal devices are safe for patients. The FDA has approved both devices for procedures like those in this trial, confirming they meet safety standards.

Studies have found that Statseal effectively reduces bleeding and improves patient outcomes. It remains localized and is unlikely to cause allergic reactions. Statseal has also passed safety tests for use with the body.

Perclose is commonly used in medical procedures to close artery punctures. Although specific safety data isn't provided here, its FDA approval indicates it is generally safe when used correctly.

In summary, both devices are well-tolerated, with no major safety concerns reported in studies or through their FDA approvals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Statseal and Perclose treatment approach because it aims to improve hemostasis during cardiovascular procedures. While standard treatments usually rely on manual compression and devices like Perclose alone, the addition of the Statseal disc represents a potentially faster and more effective way to control bleeding. The Statseal disc is designed to seal the puncture site more efficiently, potentially reducing the time to ambulation and enhancing patient recovery. This combination could streamline patient care and minimize post-operative complications, which is why it's generating interest in the medical community.

What evidence suggests that these devices are effective for achieving hemostasis in cardiovascular procedures?

Research shows that the Statseal device helps reduce bleeding at catheter insertion sites. Studies have found that using Statseal can improve patient outcomes by decreasing bleeding and related issues. Without Statseal, more than 60% of cases experience bleeding again after one hour, and 50% still bleed after two hours. Statseal can help blood clot faster and more reliably at the site, possibly reducing the need for extra pressure and treatments. In this trial, one group of participants will receive only the Perclose device, which the FDA has approved for stopping bleeding during certain procedures and is widely used for this purpose. Another group will receive both the Perclose and Statseal devices together, aiming to improve the sealing process and speed up recovery. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

Citations

1. statseal.com statseal.com/interventional-cardiology/

Interventional Cardiology – StatSeal These trials also demonstrate what happens without StatSeal use; more than 60% of cases rebleed after 1 hour and 50% still rebleed after 2 hours.

2. britishjournalofnursing.com britishjournalofnursing.com/content/product-focus/rapid-haemostasis-to-achieve-dressing-longevity-evaluation-trial-results-using-statseal-catheter-exit-site-protection/

evaluation trial results using StatSeal catheter exit site ... The findings demonstrate StatSeal's effectiveness in improving patient outcomes by reducing exit site bleeding and associated complications, ...

3. biolife.com biolife.com/wp-content/uploads/Hastings-2024-Rapid-haemostasis-to-achieve-dressing-longevity-using-StatSeal.pdf

evaluation trial results using StatSeal catheter exit site ... The findings demonstrate StatSeal's effectiveness in improving patient outcomes by reducing exit site bleeding and associated complications, ...

4. statseal.com statseal.com/central-venous-catheters/

Central Venous Catheters – StatSeal The conclusion indicated “Using StatSeal improved patient outcomes and reduced the number of dressing changes required in a 7-day period, saving time and money.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06451185

Statseal® for Central Venous Catheter Insertion Sites in ... This powder product aids clotting at the level of the skin, meaning that it prevents or reduces bleeding while helping to maintain a dry and protected ...

6. statseal.com statseal.com/interventional-radiology/

Interventional Radiology All StatSeal products are non-systemic, hypoallergenic, have no age contraindications, and have passed all FDA-required biocompatibility testing. Whether it's a ...

7. scispace.com scispace.com/pdf/use-of-statseal-advanced-disc-to-decrease-time-to-hemostasis-177q7q29vn.pdf

use-of-statseal-advanced-disc-to-decrease-time-to- ... It found the Statseal powder to be superior in reducing manual compression time with no difference in vascular complications [8]. This study did not evaluate ...