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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closer VSS | Experimental | Rex Medical Closer Vascular Sealing System to close femoral arteriotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closer VSS | Device | At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Hemostasis | Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis | procedural, usually within 15 minutes of enrollment |
| Rate of Combined Major Access Site Closure-related Complications | Primary safety endpoint - rate of combined major access site closure-related complications | Through 30 days +/- 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | prior to hospital discharge, usually within 24 hours |
| Time to Discharge Eligibility |
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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:
- 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
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| Name | Affiliation | Role |
|---|---|---|
| Shing-Chiu Wong, MD | New York Presbyterian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States | ||
| Colorado Neurological Institute |
After multi-center manuscript is published.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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) |
| prior to hospital discharge, usually within 24 hours |
| 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 | through hospital discharge, usually within 24 hours |
| 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 | procedural, usually within 15 minutes of enrollment |
| Rate of Combined Minor Access Site Closure-related Complications | Secondary safety endpoint - rate of combined minor access site closure-related complications | through 30 +/- 7 days |
| 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 | through 30 days +/- 7 days |
| Englewood |
| Colorado |
| 80113 |
| United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Lafayette General Medical Center/Cardiovascular Institute of the South | Lafayette | Louisiana | 70503 | United States |
| New York Presbyterian Hospital | New York | New York | 10065 | United States |
| North Ohio Research | Elyria | Ohio | 44035 | United States |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239-3098 | United States |
| Geisinger Health Center | Danville | Pennsylvania | 17822 | United States |
| Geisinger Health Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Pinnacle Health | Wormleysburg | Pennsylvania | 17043 | United States |
| Heart Hospital of Austin | Austin | Texas | 78756 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Closer VSS - Diagnostic Cohort | Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in diagnostic endovascular cases. Closer VSS: At the end of a percutaneous diagnostic endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis. |
| BG001 | Closer VSS - Interventional Cohort | Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in interventional endovascular cases. Closer VSS: At the end of a percutaneous interventional endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Hemostasis | Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis | All subjects enrolled | Posted | Mean | 95% Confidence Interval | minutes | procedural, usually within 15 minutes of enrollment |
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| Primary | Rate of Combined Major Access Site Closure-related Complications | Primary safety endpoint - rate of combined major access site closure-related complications | All subjects enrolled | Posted | Number | complications | Through 30 days +/- 7 days |
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| Secondary | 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 | All subjects enrolled | Posted | Mean | 95% Confidence Interval | hours | prior to hospital discharge, usually within 24 hours |
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| Secondary | 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) | All subjects enrolled | Posted | Mean | 95% Confidence Interval | hours | prior to hospital discharge, usually within 24 hours |
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| Secondary | 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 | All subjects enrolled | Posted | Mean | 95% Confidence Interval | hours | through hospital discharge, usually within 24 hours |
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| Secondary | 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 | All subjects enrolled | Posted | Count of Participants | Participants | procedural, usually within 15 minutes of enrollment |
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| Secondary | Rate of Combined Minor Access Site Closure-related Complications | Secondary safety endpoint - rate of combined minor access site closure-related complications | All subjects enrolled | Posted | Number | complications | through 30 +/- 7 days |
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| Secondary | 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 | All subjects enrolled. | Posted | Count of Participants | Participants | through 30 days +/- 7 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 220 | 12 | 220 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious device-related adverse events, excluding endpoint events | Vascular disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-serious access site bleeding | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| S. Chiu Wong, MD | Weill Cornell Medical College | 212-746-4644 | scwong@med.cornell.edu |
| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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