An interventional study of Perclose and Statseal in Arterial Occlusion, Cardiovascular Diseases and Hematoma, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
The purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement. 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 manual pressure will be held, shorter procedure time and less complications after the procedure.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Delivery of a 14-16 French Transcatheter aortic valve replacement system
Exclusion Criteria:
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five 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. 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. This will be continued until the patient has no bleeding.
Device: Perclose
Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manual pressure will be held for at least five 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. 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. This will be continued until the patient has no bleeding.
Device: Perclose · Device: Statseal
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five 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. 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. This will be continued until the patient has no bleeding.
Also known as: Suture based hemostasis device
Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manualpressure will be held for at least five 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. 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. This will be continued until the patient has no bleeding.
Also known as: potassium ferrate disc with topical hydrophilic polymer
Time to Hemostasis
From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
Time frame: 24 hours post procedure (± 1 hour)
Patients With Hematoma
Presence of small \<5cm, medium 5-10cm, or large \>10cm hematoma based on physical exam or diagnostic imaging.
Time frame: 24 hours post procedure (± 1 hour)
| Milestone | Perclose Only | Perclose With Statseal Device |
|---|---|---|
| Started | 26 | 24 |
| Completed | 26 | 24 |
| Not completed | 0 | 0 |
From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
| minutes | Perclose Only | Perclose With Statseal Device |
|---|---|---|
| Time to Hemostasis | 5.11 ± 4.4 | 4.3 ± 4.4 |
Presence of small \<5cm, medium 5-10cm, or large \>10cm hematoma based on physical exam or diagnostic imaging.
| Participants | Perclose Only | Perclose With Statseal Device |
|---|---|---|
| Small <5cm | 0 | 0 |
| Medium 5-10cm | 0 | 0 |
| Large >10cm | 1 | 1 |
Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Perclose Only | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Perclose With Statseal Device | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(years) | Perclose Only | Perclose With Statseal Device | Total |
|---|---|---|---|
| Mean | 79.2 ± 6.8 | 80.0 ± 7.3 | 79.6 ± 7.1 |
| Sex: Female, Male(Participants) | Perclose Only | Perclose With Statseal Device | Total |
|---|---|---|---|
| Female | 9 | 8 | 17 |
| Male | 17 | 16 | 33 |
| Race and Ethnicity Not Collected(Participants) | Perclose Only | Perclose With Statseal Device | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Perclose Only | Perclose With Statseal Device | Total |
|---|---|---|---|
| United States | 26 | 24 | 50 |
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University of California, Los Angeles