The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
NCT ID: NCT02136004
Last Updated: 2017-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2014-05-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Closer VSS
Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
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)
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
18 Years
80 Years
ALL
No
Sponsors
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Rex Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Shing-Chiu Wong, MD
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterian Hospital
Locations
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UC Davis Medical Center
Sacramento, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Lafayette General Medical Center/Cardiovascular Institute of the South
Lafayette, Louisiana, United States
New York Presbyterian Hospital
New York, New York, United States
North Ohio Research
Elyria, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Geisinger Health Center
Danville, Pennsylvania, United States
Geisinger Health Center
Wilkes-Barre, Pennsylvania, United States
Pinnacle Health
Wormleysburg, Pennsylvania, United States
Heart Hospital of Austin
Austin, Texas, United States
Countries
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Other Identifiers
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REX-US-2027-001
Identifier Type: -
Identifier Source: org_study_id