Femoral Arteriotomy ClosureMANTA ULTRANCT05142566
MANTA Ultrasound Closure Study
A study testing MANTA Vascular Closure Device in people with Femoral Arteriotomy Closure, run by Essential Medical, Inc. at 6 sites in 2 countries.
Trial summary
Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Femoral Arteriotomy Closure
- What is being tested?
- MANTA Vascular Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 9 Aug 2022to 11 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter valve replacement (TAVR) via a 10-20F device or sheath (12-25F OD) with common femoral artery approach
- Vessel size would allow for access for the MANTA VCD based on vessel size as determined by baseline CTA: minimum vessel diameter of 5mm for the 14F MANTA VCD and 6mm for the 18F MANTA VCD
- Understand and sign the study specific written informed consent form and PHI authorization
- Able and willing to fulfill the follow-up requirements
Who cannot join
- Patients known to be pregnant or lactating
- Patients who have a systemic infection or a local infection at or near the access site
- Patients with significant anemia (hemoglobin ≤10 g/DL)
- Patients who are morbidly obese or cachectic (BMI >40 or <20kg/m2)
- Patients with a known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
- Patients with allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
Show all 20Show fewer
- Patients with a femoral artery puncture in target groin within the prior 30 days, prior vascular closure device placement in the target common femoral artery within 3 months, or any prior target femoral artery access-related complication
- Patients who have undergone use of an intra-aortic balloon pump (IABP) through the arterial access site within 30 days prior to the baseline evaluation.
- Patients who have a Common Femoral Artery (CFA) with visible calcium and/or tortuosity, as determined by baseline CTA, precluding safe access and likely to interact with large bore access site arteriotomy, determined by investigator.
- Patients with previous iliofemoral intervention in region of access site, including but not limited to prior atherectomy, stenting, surgical or grafting procedures in the access area
- Patients in whom oral anticoagulation therapy cannot be stopped for the peri procedural period or patients with INR >1.8 at the time of the procedure
- Patients who are unable to ambulate at least 6 meters without assistance at baseline
- Patients with renal insufficiency (serum creatinine >2.5 mg/dl) or on dialysis therapy
- Patients with existing nerve damage in the ipsilateral leg
- Patients with a further planned endovascular procedure within the next 30 days
- Patients who have already participated in this IDE study
- Patients who are currently participating in another clinical study of an unapproved investigational device or drug that has not concluded the follow-up period or patient currently participating in another clinical study likely to influence hemostasis and vascular complications
- Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease
- Patients who have a common femoral artery <5mm in diameter for the 14F MANTA VCD or <6 mm in diameter for the 18F MANTA VCD, common femoral artery stenosis resulting in a vessel diameter <5mm in diameter for the 14F MANTA VCD or <6 mm in diameter for the 18F MANTA VCD, or > 50% diameter femoral or iliac artery stenosis
- Patients in whom, during initial access of the artery, arteriotomy and surrounding anatomy cannot be visualized and identified clearly under U/S imaging and/or if the vertical depth from the surface of the skin to target area of the common femoral artery measures greater than 6cm
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
University of Buffalo
Buffalo, New York, 14203
Henry Ford
Detroit, Michigan, 48202
Baylor Scott & White
Round Rock, Texas, 78665
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Sentara Northern Virginia Medical Center
Woodbridge, Virginia, 22191
About this study
Official title: Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study
Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.
Read the detailed description
The MANTA Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures.
This study is being conducted to demonstrate the safety of U/S guided closure with MANTA VCD following TAVR procedures utilizing large bore sheaths.
- Conditions
- Femoral Arteriotomy Closure
- Being tested
- MANTA Vascular Closure Device
- Keywords
- MANTA, Arterial Closure Device, Ultrasound Closure, Large Bore Closure Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MANTA Vascular Closure DeviceDevice
Evaluate the safety of ultrasound guided deployment of MANTA VCD.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Closure | Experimental | Open label, single arm study using ultrasound guidance during MANTA device deployment. Receives: Device: MANTA Vascular Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication
adapted from VARC-2 Criteria
Measured: within 30 days
Secondary outcomes (7)
Time to Hemostasis
The elapsed time between VCD deployment and first observed and confirmed arterial hemostasis.
Measured: During the procedure
Number of Patients With Technical Success
Percutaneous vascular closure is obtained without the use of unplanned endovascular or surgical intervention.
Measured: within 30 days
Number of Subjects With Ambulation Success
If a previously ambulatory patient (until day of TAVI) is able to ambulate for at least 20 feet/6 meters without re-bleeding.
Measured: During procedure admission
Time to Ambulation
The elapsed time between VCD deployment and when ambulation is achieved.
Measured: During procedure admission
Treatment Success
Time to Hemostasis ≤10 minutes and no VACR-2 Major complications
Measured: within 30 days
Procedure Time
Elapsed time from initial skin break to time when the post-deployment angiogram is completed.
Measured: During the procedure
Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication
adapted from VARC-2 Criteria
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start9 Aug 2022
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Why it stopped: Ineffective enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Femoral Arteriotomy ClosureStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essential Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teleflex
- Responsible party
- Sponsor
- Investigators
- David Wood, Principal investigator, Vancouver General HospitalVijay Iyer, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142566
- Sponsor's protocol ID
- ST-3370
- Acronym
- MANTA ULTRA
- Status last verified
- Mar 2023
- First submitted
- 10 Nov 2021
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The data obtained will be used, without mentioning Subject PHI, to assess the results of the research, and the data could be used in the future with regard to this study or other studies. The data can be passed on to the health authorities for the purposes of registering the medical device.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study
- ClinicalTrials.gov ID
- NCT05142566
- Acronym / sponsor ID
- MANTA ULTRA / ST-3370
- Conditions
- Femoral Arteriotomy Closure
- Keywords
- MANTA, Arterial Closure Device, Ultrasound Closure, Large Bore Closure Device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ineffective enrollment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Essential Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Teleflex
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.
Detailed description
The MANTA Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures.
This study is being conducted to demonstrate the safety of U/S guided closure with MANTA VCD following TAVR procedures utilizing large bore sheaths.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Closure | Experimental | Device: MANTA Vascular Closure DeviceOpen label, single arm study using ultrasound guidance during MANTA device deployment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter valve replacement (TAVR) via a 10-20F device or sheath (12-25F OD) with common femoral artery approach
- Vessel size would allow for access for the MANTA VCD based on vessel size as determined by baseline CTA: minimum vessel diameter of 5mm for the 14F MANTA VCD and 6mm for the 18F MANTA VCD
- Understand and sign the study specific written informed consent form and PHI authorization
- Able and willing to fulfill the follow-up requirements
Key exclusion criteria (20 listed)
- Patients known to be pregnant or lactating
- Patients who have a systemic infection or a local infection at or near the access site
- Patients with significant anemia (hemoglobin ≤10 g/DL)
- Patients who are morbidly obese or cachectic (BMI >40 or <20kg/m2)
- Patients with a known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
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 |
|---|---|---|
| MANTA Vascular Closure DeviceEvaluate the safety of ultrasound guided deployment of MANTA VCD. | Device | Ultrasound Closure |
Primary outcome
Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication
Time frame: within 30 days
adapted from VARC-2 Criteria
7 secondary outcomes
Time to Hemostasis
Time frame: During the procedure
Number of Patients With Technical Success
Time frame: within 30 days
Number of Subjects With Ambulation Success
Time frame: During procedure admission
Time to Ambulation
Time frame: During procedure admission
Treatment Success
Time frame: within 30 days
Procedure Time
Time frame: During the procedure
Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication
Time frame: within 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The data obtained will be used, without mentioning Subject PHI, to assess the results of the research, and the data could be used in the future with regard to this study or other studies. The data can be passed on to the health authorities for the purposes of registering the medical device.
Related trials for Femoral Arteriotomy Closure
Not yet recruiting
Safety and Effectiveness Clinical Study of Novelrad Vascular Closure System (NVCS)
Vascular Closure Device, Femoral Arteriotomy Closure
Active, not recruiting
The Ladera Large Bore Closure Feasibility Study
Vascular Closure, Femoral Arteriotomy Closure
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.
David Wood principal investigator
Vancouver General Hospital
Vijay Iyer principal investigator
University at Buffalo
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MANTA Vascular Closure Device in people with Femoral Arteriotomy Closure, run by Essential Medical, Inc. at 6 sites in 2 countries.
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 20 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: stopped early, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication (time frame: within 30 days). 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 27 Jul 2023.