From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
| Group | Value | 95% CI |
|---|---|---|
| Perclose Only | 5.11 | ± 4.4 |
| Perclose With Statseal Device | 4.3 | ± 4.4 |
Last reviewed · How we verify
Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure
NA trial testing Perclose in Arterial Occlusion in 50 participants. Completed in 25 July 2023.
| Lead sponsor | University of California, Los Angeles |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 12 January 2023 |
| Primary completion | 25 July 2023 |
| Estimated completion | 25 July 2023 |
| Sites | 1 location across United States |
University of California, Los Angeles
18 and older, any sex, with Arterial Occlusion or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
| Group | Value | 95% CI |
|---|---|---|
| Perclose Only | 5.11 | ± 4.4 |
| Perclose With Statseal Device | 4.3 | ± 4.4 |
Presence of small \<5cm, medium 5-10cm, or large \>10cm hematoma based on physical exam or diagnostic imaging.
| Group | Value | 95% CI |
|---|---|---|
| Perclose Only | 0 | |
| Perclose With Statseal Device | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Perclose Only | 0 | |
| Perclose With Statseal Device | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Perclose Only | 1 | |
| Perclose With Statseal Device | 1 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05637970.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing