CloserThe 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
Closer VSS
Surgical Wound
+ Wounds and Injuries
Treatment Study
Summary
Study start date: May 1, 2014
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.220 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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: 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
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 12 locations
Colorado Neurological Institute
Englewood, United StatesWashington Hospital Center
Washington D.C., United StatesLafayette General Medical Center/Cardiovascular Institute of the South
Lafayette, United States