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

NCT02136004 | Completed Results DMC

• 1 other identifier: REX-US-2027-001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 12

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.

Conditions

Surgical Wound

Keywords

arteriotomy; vessel closure; femoral access site

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Time to Ambulation

  prior to hospital discharge, usually within 24 hours

• Time to Discharge Eligibility

  prior to hospital discharge, usually within 24 hours

• Time to Hospital Discharge

  through hospital discharge, usually within 24 hours

• Device Success

  procedural, usually within 15 minutes of enrollment

• Rate of Combined Minor Access Site Closure-related Complications

  through 30 +/- 7 days

Study Arms (1)

Closer VSS

EXPERIMENTAL

Rex Medical Closer Vascular Sealing System to close femoral arteriotomy

Device: Closer VSS

Interventions

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.

Also known as: Rex Medical Closer TM Vascular Sealing System (VSS)

Closer VSS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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)
• \- 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

Sponsors & Collaborators

• Rex Medical: lead

Study Sites (12)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Colorado Neurological Institute

Englewood, Colorado, 80113, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Lafayette General Medical Center/Cardiovascular Institute of the South

Lafayette, Louisiana, 70503, United States

Location

New York Presbyterian Hospital

New York, New York, 10065, United States

Location

North Ohio Research

Elyria, Ohio, 44035, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Geisinger Health Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Health Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Pinnacle Health

Wormleysburg, Pennsylvania, 17043, United States

Location

Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: S. Chiu Wong, MD
• Organization: Weill Cornell Medical College

scwong@med.cornell.edu

212-746-4644

Study Officials

• Shing-Chiu Wong, MD

  New York Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 12, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 27, 2017
• Results First Posted: December 29, 2016

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

US (12)