The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
- Conditions
- Surgical Wound
- Interventions
- Device: Closer VSS
- Registration Number
- NCT02136004
- Lead Sponsor
- Rex Medical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Closer VSS Closer VSS Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
- Primary Outcome Measures
Name Time Method Time to Hemostasis procedural, usually within 15 minutes of enrollment 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 Through 30 days +/- 7 days Primary safety endpoint - rate of combined major access site closure-related complications
- Secondary Outcome Measures
Name Time Method Time to Ambulation prior to hospital discharge, usually within 24 hours 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
Rate of Combined Minor Access Site Closure-related Complications through 30 +/- 7 days Secondary safety endpoint - rate of combined minor access site closure-related complications
Time to Hospital Discharge through hospital discharge, usually within 24 hours Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward
Time to Discharge Eligibility prior to hospital discharge, usually within 24 hours 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)
Device Success procedural, usually within 15 minutes of enrollment 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
Procedure Success through 30 days +/- 7 days Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days
Trial Locations
- Locations (11)
New York Presbyterian Hospital
🇺🇸New York, New York, United States
North Ohio Research
🇺🇸Elyria, Ohio, United States
Pinnacle Health
🇺🇸Wormleysburg, Pennsylvania, United States
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Lafayette General Medical Center/Cardiovascular Institute of the South
🇺🇸Lafayette, Louisiana, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Washington Hospital Center
🇺🇸Washington, D.C., District of Columbia, United States
Geisinger Health Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States