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

NCT01873898 | Completed FDA Device

• 1 other identifier: REX-OUS-2027-004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

femoral artery; access site; hemostasis

Outcome Measures

Primary Outcomes (2)

• Time to Ambulation

  Time to Ambulation - in minutes, defined as the time from when hemostasis is achieved to the time when ambulation is achieved (patient standing and walking at least 6.1 meters \[20 feet\] without re-bleeding).

  Day 0

• Frequency of Major Adverse Events through 30 days

  The primary safety endpoint is the frequency of Major Adverse Events through 30 days, defined as one of the following events related to the use of the investigational device: a hematoma requiring a transfusion, a device embolization, false aneurysm requiring intervention or a retroperitoneal bleed.

  30 days

Secondary Outcomes (3)

• Time to Hemostasis

  Day 0

• Placement Technical Success

  Day 0

• Clinical Success

  Day 0

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Device: Rex Medical Closer™ Vascular Closure System

Interventions

Rex Medical Closer™ Vascular Closure System 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.

Also known as: Closer™

Single Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rex Medical: lead

Study Sites (1)

Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular

Asunción, Paraguay

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian Ebner, MD

  Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 10, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

PA (1)