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

Study Overview
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Brief Summary
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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.

Detailed Description
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The objective of the trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System (VSS) in sealing femoral arterial access sites and providing reduced times to hemostasis (TTH) compared with performance goals at the completion of diagnostic or interventional procedures performed through 5, 6 or 7 Fr procedural sheaths. This study will be considered a success (from a statistical perspective) if it meets both the Closer VSS superiority goal for the primary effectiveness analysis and the Closer VSS performance goal for the primary safety analysis.

Official Title
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The Closer Trial: A Multi-center, Prospective, Single Arm Trial to Evaluate the Safety and Efficacy of the Rex Medical Closer Vascular Sealing System (VSS) for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures

Conditions
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Surgical Wound

Intervention / Treatment
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* Device: Closer VSS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-Op Inclusion Criteria: 1 - Acceptable candidates for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 5, 6, or 7 Fr introducer sheath. - Exclusion Criteria: Pre-Operative 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 - Extreme morbid obesity (BMI > 4 kg/m2) Intra-operative Exclusion Criteria: - Use of a procedural sheath that is < 5 Fr or > 7 Fr - Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure - Placement of an ipsilateral venous sheath for procedure - Procedural sheath placement either through the superficial femoral artery and into the profunda femoris artery, or placement at or distal to bifurcation of the superficial femoral artery and the profunda femoris artery - In subjects receiving unfractionated heparin, an ACT > 350 seconds, or > 250 seconds in the presence of a GP IIb/IIIa inhibitor - Procedures or existing medical conditions that may extend index hospitalization beyond 24 hours post-procedure - Systemic hypertension (SBP > 180 mmHg) or hypotension (SBP < 90 mmHg) just prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closer VSS<br>Rex Medical Closer Vascular Sealing System to close femoral arteriotomy | Device: Closer VSS<br>* At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.<br>* Other names: Rex Medical Closer TM Vascular Sealing System (VSS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Hemostasis | Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis | procedural, usually within 15 minutes of enrollment | 
| Rate of Combined Major Access Site Closure-related Complications | Primary safety endpoint - rate of combined major access site closure-related complications | Through 30 days +/- 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Ambulation | Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site | prior to hospital discharge, usually within 24 hours | 
| Time to Discharge Eligibility | Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s) | prior to hospital discharge, usually within 24 hours | 
| Time to Hospital Discharge | Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward | through hospital discharge, usually within 24 hours | 
| Device Success | Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression | procedural, usually within 15 minutes of enrollment | 
| Rate of Combined Minor Access Site Closure-related Complications | Secondary safety endpoint - rate of combined minor access site closure-related complications | through 30 +/- 7 days | 
| Procedure Success | Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days | through 30 days +/- 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arteriotomy, vessel closure, femoral access site