Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01873898|
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bleeding||Device: Rex Medical Closer™ Vascular Closure System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Experimental: 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.
Device: 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.
Other Name: Closer™
- Time to Ambulation [ Time Frame: Day 0 ]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).
- Frequency of Major Adverse Events through 30 days [ Time Frame: 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.
- Time to Hemostasis [ Time Frame: Day 0 ]Time to Hemostasis - in minutes, defined as the time from when the delivery system releases both sutures, which are attached to the sealing member, to the time that hemostasis (absence of expanding or developing hematoma) is achieved
- Placement Technical Success [ Time Frame: Day 0 ]Placement Technical Success - defined as the successful deployment of the device at the intended placement site such that hemostasis is achieved.
- Clinical Success [ Time Frame: Day 0 ]Clinical Success - evaluated from the time of device deployment, and defined as Placement Technical Success in the absence of any major safety endpoint including subsequent hematoma requiring a transfusion, a device embolization, false aneurysm requiring intervention, or retroperitoneal bleeding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873898
|Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular|
|Principal Investigator:||Adrian Ebner, MD||Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular|