Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial

NCT ID: NCT01873898

Last Updated: 2017-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-07-31

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the Rex Medical Closer™ Vascular Closure System to close the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures with early ambulation and discharge.

Conditions

Bleeding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single Arm

This is a single arm, prospective study to collect data on the safety and effectiveness of the Rex Medical Closer™ Vascular Closure System. Only subjects who are scheduled to undergo an interventional diagnostic procedure that requires closure of the femoral access site are eligible for study participation.

Group Type: EXPERIMENTAL

Rex Medical Closer™ Vascular Closure System

Intervention Type: DEVICE

The Rex Medical CloserTM Vascular Closure System is currently being investigated for use in closing and reducing time to hemostasis at the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures or interventional procedures using up to a 7 French procedural sheath. This study will evaluate the safety and efficacy of the Rex Medical CloserTM Vascular Closure System to close the femoral artery access site of subjects who have undergone diagnostic angiography procedures with early ambulation and discharge as soon as possible after sheath removal and device placement.

Interventions

Rex Medical Closer™ Vascular Closure System

The Rex Medical CloserTM Vascular Closure System is currently being investigated for use in closing and reducing time to hemostasis at the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures or interventional procedures using up to a 7 French procedural sheath. This study will evaluate the safety and efficacy of the Rex Medical CloserTM Vascular Closure System to close the femoral artery access site of subjects who have undergone diagnostic angiography procedures with early ambulation and discharge as soon as possible after sheath removal and device placement.

Intervention Type: DEVICE

Other Intervention Names

Closer™

Eligibility Criteria

Inclusion Criteria

• Subject is > 18 years of age.
• Subject is able to undergo diagnostic angiography procedure and is found suitable to receive such a device at the femoral arterial puncture site in order to reduce time to hemostasis.
• Subject or his/her legal guardian understands the nature of the procedure, and provides written informed consent prior to the procedure.
• Subject is available and willing to participate in follow-up through 30 days post femoral closure.

Exclusion Criteria

• Subject with known allergies to polylactic acid (PLA), polyglycolic acid (PGA) or polydioxanone (PDO) polymers
• Subject with severe acute non-cardiac systemic disease
• Subject with evidence of systemic infection
• Subject where bacterial contamination of the procedural sheath or surrounding tissues may have occurred as this may increase risk of infection
• Subject with coagulopathy (bleeding disorders, including thrombocytopenia, hemophilia, etc.)
• Subject taking thrombolytic medication which reduces fibrinogen to less than 100 mg/dl
• Subject who has had a previous arterial access in the femoral artery on the treatment side with an existing hematoma >5 cm in diameter
• Subject who is unable to ambulate at baseline
• Subject who has had another closure device used in the treatment side within the previous 90 days
• Subject who requires re-entry of the treatment side planned within the next 90 days post-procedure
• Subject has a history of surgical repair on the treatment side
• Subject has planned surgeries for any reason within 90 days post- procedure
• Subject is pregnant or is lactating (non-pregnancy must be confirmed by testing)
• Has a history of a psychiatric condition, substance abuse or alcohol abuse that, in the opinion of the investigator, will potentially interfere with his or her participation
• Subject has been previously enrolled in the Rex Closer™ study
• Subject who is currently or within the previous 4 weeks been enrolled in another investigational device or drug trial
• Subject is incarcerated at the time of enrollment
• Subject where the procedural sheath has been placed through the superficial femoral artery and into the profundafemoris
• Subject where the procedure puncture site is at or distal to the bifurcation of the superficial femoral profundafemoris artery, as this may result in 1) the intravascular sealing patch catching on the bifurcation or being positioned incorrectly, and/or 2) intravascular deployment of the device into the vessel (These events may reduce blood flow through the vessel leading to symptoms of distal arterial insufficiency.)
• Subject's procedure was accessed through a vascular graft
• Subjects with uncontrolled hypertension (> 230 mm Hg systolic)
• Subjects with small femoral artery size (Less than 5 mm in diameter)
• Subjects with stenosis > 50% at the vicinity of the femoral arterial puncture site
• Subjects with anomalous branches or vessel abnormalities present in the vicinity of the femoral arterial puncture site

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rex Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Ebner, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular

Locations

Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular

Asunción, , Paraguay

Countries

Paraguay

Other Identifiers

REX-OUS-2027-004

Identifier Type: -

Identifier Source: org_study_id