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Comparison of Figure-Of-Eight Suture Perclose ProGlide Suture-Mediated Closure

Comparison of Figure-Of-Eight Suture and Perclose ProGlide Suture-Mediated Closure System in Achieving Hemostasis After a Large Bore Venous Access.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04831008
Enrollment
50
Registered
2021-04-05
Start date
2020-08-06
Completion date
2022-12-13
Last updated
2023-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Puncture

Keywords

Perclose Device, Figure-of-eight suture

Brief summary

The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.

Detailed description

Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.

Interventions

OTHERFigure-of-eight suture

Using the figure-of-eight closure technique when closing access for structural heart therapies.

OTHERPerclose Device

Using the Perclose device when closing access for structural heart therapies.

Sponsors

Florida Atlantic University
CollaboratorOTHER
Delray Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.

Exclusion criteria

* Patients who do not consent * Minors or those unable to consent

Design outcomes

Primary

MeasureTime frameDescription
Hemostasis TimeImmediateTo assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access
Procedure TimeImmediate
Access Site Complication1 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026