CompletedNot Applicable

The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System

United States220 participantsStarted 2014-05

Plain-language summary

The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. \- Significant bleeding diatheses or coagulopathy
✕. \- Planned endovascular or surgical procedures within next 30 days
✕. \- Planned ipsilateral femoral arteriotomy within next 90 days
✕. \- Arteriotomy in ipsilateral groin within the past 30 days with any residual hematoma, significant bruising or vascular complication
✕. \- Previous vessel closure device used in ipsilateral groin within the past 90 days
✕. \- Previous vascular surgery or repair in the vicinity of the target access site
✕. \- Severe peripheral vascular disease in the ipsilateral limb requiring surgical or endovascular treatment within the pervious 30 days or next 30 days
✕. \- Existing nerve damage in ipsilateral limb

What they're measuring

Time to Hemostasis

Timeframe: procedural, usually within 15 minutes of enrollment

Rate of Combined Major Access Site Closure-related Complications

Timeframe: Through 30 days +/- 7 days

Trial details

NCT IDNCT02136004

SponsorRex Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

Results submitted2016-11-01

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