The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System

Surgical Wound Clinical Trial

— Closer  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136004
• Other study ID #: REX-US-2027-001
• Status: Completed
• Phase: N/A
• First received: May 7, 2014
• Last updated: September 26, 2017
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: September 2017
• Source: Rex Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Heart Hospital of Austin	Austin	Texas
United States	Geisinger Health Center	Danville	Pennsylvania
United States	North Ohio Research	Elyria	Ohio
United States	Colorado Neurological Institute	Englewood	Colorado
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	Oregon Health & Science University	Portland	Oregon
United States	UC Davis Medical Center	Sacramento	California
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Washington Hospital Center	Washington, D.C.	District of Columbia
United States	Geisinger Health Center	Wilkes-Barre	Pennsylvania
United States	Pinnacle Health	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rex Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
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	prior to hospital discharge, usually within 24 hours
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)	prior to hospital discharge, usually within 24 hours
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	through hospital discharge, usually within 24 hours
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	procedural, usually within 15 minutes of enrollment
Secondary	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
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	through 30 days +/- 7 days