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

Primary Purpose

Surgical Wound

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Closer VSS
Sponsored by
Rex Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound focused on measuring arteriotomy, vessel closure, femoral access site

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Medical Center
  • Colorado Neurological Institute
  • Washington Hospital Center
  • Lafayette General Medical Center/Cardiovascular Institute of the South
  • New York Presbyterian Hospital
  • North Ohio Research
  • Oklahoma Heart Institute
  • Oregon Health & Science University
  • Geisinger Health Center
  • Geisinger Health Center
  • Pinnacle Health
  • Heart Hospital of Austin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Closer VSS

Arm Description

Rex Medical Closer Vascular Sealing System to close femoral arteriotomy

Outcomes

Primary Outcome Measures

Time to Hemostasis
Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis
Rate of Combined Major Access Site Closure-related Complications
Primary safety endpoint - rate of combined major access site closure-related complications

Secondary Outcome Measures

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
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)
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
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
Rate of Combined Minor Access Site Closure-related Complications
Secondary safety endpoint - rate of combined minor access site closure-related complications
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

Full Information

First Posted
May 7, 2014
Last Updated
September 26, 2017
Sponsor
Rex Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02136004
Brief Title
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
Acronym
Closer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rex Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound
Keywords
arteriotomy, vessel closure, femoral access site

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closer VSS
Arm Type
Experimental
Arm Description
Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Intervention Type
Device
Intervention Name(s)
Closer VSS
Other Intervention Name(s)
Rex Medical Closer TM Vascular Sealing System (VSS)
Intervention Description
At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Primary Outcome Measure Information:
Title
Time to Hemostasis
Description
Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis
Time Frame
procedural, usually within 15 minutes of enrollment
Title
Rate of Combined Major Access Site Closure-related Complications
Description
Primary safety endpoint - rate of combined major access site closure-related complications
Time Frame
Through 30 days +/- 7 days
Secondary Outcome Measure Information:
Title
Time to Ambulation
Description
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
Time Frame
prior to hospital discharge, usually within 24 hours
Title
Time to Discharge Eligibility
Description
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)
Time Frame
prior to hospital discharge, usually within 24 hours
Title
Time to Hospital Discharge
Description
Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward
Time Frame
through hospital discharge, usually within 24 hours
Title
Device Success
Description
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
Time Frame
procedural, usually within 15 minutes of enrollment
Title
Rate of Combined Minor Access Site Closure-related Complications
Description
Secondary safety endpoint - rate of combined minor access site closure-related complications
Time Frame
through 30 +/- 7 days
Title
Procedure Success
Description
Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days
Time Frame
through 30 days +/- 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shing-Chiu Wong, MD
Organizational Affiliation
New York Presbyterian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Washington Hospital Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Lafayette General Medical Center/Cardiovascular Institute of the South
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
North Ohio Research
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Geisinger Health Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Geisinger Health Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Pinnacle Health
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Heart Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After multi-center manuscript is published.

Learn more about this trial

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

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