Clinical trial NCT02136004: The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
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
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Keywords: arteriotomy
vessel closure
femoral access site
Lead sponsor: Rex Medical
Sponsor class: INDUSTRY
First posted: 2014-05-12
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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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

Primary outcomes:
measure: Time to Hemostasis
timeFrame: procedural, usually within 15 minutes of enrollment
measure: Rate of Combined Major Access Site Closure-related Complications
timeFrame: Through 30 days +/- 7 days
Secondary outcomes:
measure: Time to Ambulation
timeFrame: prior to hospital discharge, usually within 24 hours
measure: Time to Discharge Eligibility
timeFrame: prior to hospital discharge, usually within 24 hours
measure: Time to Hospital Discharge
timeFrame: through hospital discharge, usually within 24 hours
measure: Device Success
timeFrame: procedural, usually within 15 minutes of enrollment
measure: Rate of Combined Minor Access Site Closure-related Complications
timeFrame: through 30 +/- 7 days
measure: Procedure Success
timeFrame: through 30 days +/- 7 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Washington, D.C.
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Lafayette
country: United States
facility: Lafayette General Medical Center/Cardiovascular Institute of the South
state: Louisiana
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Elyria
country: United States
facility: North Ohio Research
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Danville
country: United States
facility: Geisinger Health Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Health Center
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
Study officials:
affiliation: New York Presbyterian Hospital
name: Shing-Chiu Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: