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

Rex Medical

Status: Completed

Conditions: Surgical Wound

Treatments: Device: Closer VSS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02136004

REX-US-2027-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

Closer VSS

Experimental group

Description:

Rex Medical Closer Vascular Sealing System to close femoral arteriotomy

Treatment:

Device: Closer VSS