BleedingNCT01873898
Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial
A study testing Rex Medical Closer™ Vascular Closure System in people with Bleeding, run by Rex Medical at 1 site in Paraguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding
- What is being tested?
- Rex Medical Closer™ Vascular Closure System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteParaguay
- Study dates
- Jun 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Paraguay1 site
Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular
Asunción
About this study
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
- Being tested
- Rex Medical Closer™ Vascular Closure System
- Keywords
- femoral artery, access site, hemostasis
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rex Medical Closer™ Vascular Closure SystemDevice
Also called Closer™
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Rex Medical Closer™ Vascular Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 30 days
Secondary outcomes (3)
Time to Hemostasis
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
Measured: Day 0
Placement Technical Success
Placement Technical Success - defined as the successful deployment of the device at the intended placement site such that hemostasis is achieved.
Measured: Day 0
Clinical Success
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rex Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Ebner, MD, Principal investigator, Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873898
- Sponsor's protocol ID
- REX-OUS-2027-004
- Status last verified
- Sep 2017
- First submitted
- 6 Jun 2013
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial
- ClinicalTrials.gov ID
- NCT01873898
- Acronym / sponsor ID
- REX-OUS-2027-004
- Conditions
- Bleeding
- Keywords
- femoral artery, access site, hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rex MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Rex Medical Closer™ Vascular Closure SystemThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rex Medical Closer™ Vascular Closure SystemAlso: Closer™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. | Device | Single Arm |
Primary outcome
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.
3 secondary outcomes
Time to Hemostasis
Time frame: Day 0
Placement Technical Success
Time frame: Day 0
Clinical Success
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Ebner, MD principal investigator
Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rex Medical Closer™ Vascular Closure System in people with Bleeding, run by Rex Medical at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Ambulation (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.