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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound
• Intervention / Treatment: Device: Closer VSS

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Colorado Neurological Institute
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20010
      • Washington Hospital Center
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Lafayette General Medical Center/Cardiovascular Institute of the South
  • New York
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital
  • Ohio
    • Elyria, Ohio, United States, 44035
      • North Ohio Research
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health & Science University
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health Center
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Health Center
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health
  • Texas
    • Austin, Texas, United States, 78756
      • Heart Hospital of Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

9. - Extreme morbid obesity (BMI > 4 kg/m2)

   Intra-operative Exclusion Criteria:

10. - Use of a procedural sheath that is < 5 Fr or > 7 Fr
11. - Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure
12. - Placement of an ipsilateral venous sheath for procedure
13. - 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
14. - In subjects receiving unfractionated heparin, an ACT > 350 seconds, or > 250 seconds in the presence of a GP IIb/IIIa inhibitor
15. - Procedures or existing medical conditions that may extend index hospitalization beyond 24 hours post-procedure
16. - Systemic hypertension (SBP > 180 mmHg) or hypotension (SBP < 90 mmHg) just prior to enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rex Medical
• Investigators: Principal Investigator: Shing-Chiu Wong, MD, New York Presbyterian Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 12, 2014

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: vessel closure; arteriotomy; femoral access site
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: REX-US-2027-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: After multi-center manuscript is published.