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

Completed · Not applicable

Conditions studied: Surgical Wound

In brief

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.

Key facts

Study ID

NCT02136004

Run by

Rex Medical

People needed

220

Starts

2014-05-01

Expected to finish

2015-02-01

Last updated by the study team

2017-10-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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