Femoral Arteriotomy ClosureACCESS MANTANCT05936996
Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
An observational study of Femoral Arteriotomy Closure, run by Essential Medical, Inc. at 10 sites in 2 countries.
Trial summary
This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. 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
- How many people
- 258 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 15 Nov 2023to 30 Oct 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
Study population: Qualifying subjects undergoing TAVR using the MANTA® VCD for large bore closure.
Who may be able to join
- Candidate meets criteria for on-label use of MANTA® VCD as specified in the country-specific MANTA® VCD Instructions for Use (IFU), per judgement of the investigator.
- Age ≥21 years
Who cannot join
- Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
University at Buffalo
Buffalo, New York, 14203
Henry Ford Health
Detroit, Michigan, 48202
Baptist Health Medical Center-Jacksonville
Jacksonville, Florida, 32207
North Shore University Hospital
Manhasset, New York, 11030
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai Hospital
New York, New York, 10029
Montefiore Medical Center
New York, New York, 10467
Orlando Health, Inc
Orlando, Florida, 32806
Baylor Scott & White - Round Rock
Round Rock, Texas, 78665
About this study
This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. The purpose of this study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.
Read the detailed description
In the U.S. and Canada, 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. In Israel, the 14F MANTA® is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA® device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F). The purpose of the study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.
- Conditions
- Femoral Arteriotomy Closure
- Being tested
- MANTA Vascular Closure Device
- Keywords
- MANTA, Arterial Closure Device, 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
The MANTA® Vascular Closure Device consists of a 14F or 18F MANTA® Closure Device, a 14F or 18F Sheath with Introducer, and an 8F Depth Locator. In the U.S. and Canada, 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of VARC-3 Major & Minor Vascular Complications
Percentage of participants with one or more VARC-3 Major or Minor complications assessed through 30 days following the procedure using Valve Academic Research Consortium-3 endpoint definitions. Reported events were reviewed and classified as major or minor according to the VARC-3 criteria by the study clinical events committee.
Measured: within 30 days of TAVR procedure
Time to Hemostasis
The elapsed time between MANTA® deployment and first observed and confirmed arterial hemostasis
Measured: During the procedure
Secondary outcomes (6)
Additional Interventions: Required at Large Bore Access Site to Address Complications
The percentage of subjects with additional interventions required at large bore access site to address bleeding or other large bore access site complications (e.g., bare or covered stent or surgical repair), within 30 days following the procedure
Measured: within 30 days following the procedure
Discharge Readiness
Percentage of participants assessed as fit for discharge by the site's Most Responsible Operator on the first full calendar day following the procedure. Fitness for discharge was defined as the ability to walk 20 feet (6 meters), absence of orthostatic hypotension, ability to void, and a stable access site without bleeding or expansion of a pre-existing hematoma.
Measured: Post-Op, day 1
Technical Success:
The percentage of subjects in whom closure is obtained with the MANTA® VCD without the use of unplanned endovascular or surgical intervention
Measured: During the procedure
Ambulation Success:
Percentage of previously ambulatory subjects who were able to ambulate at least 20 feet/6 meters without re-bleeding following the procedure.
Measured: Post-op day 1
Treatment Success:
The percentage of subjects in whom the time to Hemostasis ≤10 minutes and have no Large Bore Access Related Major VARC-3 complications within 30 days.
Measured: within 30 days of TAVR procedure
Procedure Time
Elapsed time from initial skin break to time when the post-deployment angiogram is completed
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start15 Nov 2023
- Primary completion20 Jun 2025
- Study completion30 Oct 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 258 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Essential Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vascular Solutions LLC, Teleflex Medical Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936996
- Sponsor's protocol ID
- ST-3659
- Acronym
- ACCESS MANTA
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2023
- Last updated
- 23 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
- ClinicalTrials.gov ID
- NCT05936996
- Acronym / sponsor ID
- ACCESS MANTA / ST-3659
- Conditions
- Femoral Arteriotomy Closure
- Keywords
- MANTA, Arterial Closure Device, Large Bore Closure Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Essential Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vascular Solutions LLC, Teleflex Medical Inc
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Posted 23 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. The purpose of this study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.
Detailed description
In the U.S. and Canada, 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. In Israel, the 14F MANTA® is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA® device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F). The purpose of the study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Qualifying subjects undergoing TAVR using the MANTA® VCD for large bore closure.
Key inclusion criteria (2 listed)
- Candidate meets criteria for on-label use of MANTA® VCD as specified in the country-specific MANTA® VCD Instructions for Use (IFU), per judgement of the investigator.
- Age ≥21 years
Key exclusion criteria (1 listed)
- Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.
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 DeviceThe MANTA® Vascular Closure Device consists of a 14F or 18F MANTA® Closure Device, a 14F or 18F Sheath with Introducer, and an 8F Depth Locator. In the U.S. and Canada, 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. | Device | – |
Primary outcome
Rate of VARC-3 Major & Minor Vascular Complications
Time frame: within 30 days of TAVR procedure
Percentage of participants with one or more VARC-3 Major or Minor complications assessed through 30 days following the procedure using Valve Academic Research Consortium-3 endpoint definitions. Reported events were reviewed and classified as major or minor according to the VARC-3 criteria by the study clinical events committee.
Time to Hemostasis
Time frame: During the procedure
The elapsed time between MANTA® deployment and first observed and confirmed arterial hemostasis
6 secondary outcomes
Additional Interventions: Required at Large Bore Access Site to Address Complications
Time frame: within 30 days following the procedure
Discharge Readiness
Time frame: Post-Op, day 1
Technical Success:
Time frame: During the procedure
Ambulation Success:
Time frame: Post-op day 1
Treatment Success:
Time frame: within 30 days of TAVR procedure
Procedure Time
Time frame: Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Arteriotomy Closure, run by Essential Medical, Inc. at 10 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 2 inclusion and 1 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 23 Oct 2026). 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 VARC-3 Major & Minor Vascular Complications (time frame: within 30 days of TAVR procedure). 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 23 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.