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NCT05637970

Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure

Completed NA Results posted Last updated 19 February 2025
What this trial tests

NA trial testing Perclose in Arterial Occlusion in 50 participants. Completed in 25 July 2023.

Timeline
12 January 2023
Primary endpoint
25 July 2023
25 July 2023

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment50
Start date12 January 2023
Primary completion25 July 2023
Estimated completion25 July 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

18 and older, any sex, with Arterial Occlusion or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Hemostasis Primary · 24 hours post procedure (± 1 hour)

From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.

GroupValue95% CI
Perclose Only5.11± 4.4
Perclose With Statseal Device4.3± 4.4
Patients With Hematoma Secondary · 24 hours post procedure (± 1 hour)

Presence of small \<5cm, medium 5-10cm, or large \>10cm hematoma based on physical exam or diagnostic imaging.

Small <5cm
GroupValue95% CI
Perclose Only0
Perclose With Statseal Device0
Medium 5-10cm
GroupValue95% CI
Perclose Only0
Perclose With Statseal Device0
Large >10cm
GroupValue95% CI
Perclose Only1
Perclose With Statseal Device1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Perclose

Trials testing the same drug.

Other recruiting trials for Arterial Occlusion

Currently open trials in the same condition.

Other University of California, Los Angeles trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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