Femoral Arteriotomy ClosureMARVELNCT03330002
MANTA Registry for Vascular Large-bore Closure
An observational study of Femoral Arteriotomy Closure, run by Essential Medical, Inc. at 9 sites in 5 countries.
Trial summary
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Arteriotomy Closure
- What is being tested?
- CE-marked MANTA vascular closure device (VCD)
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 23 Feb 2018to 1 Feb 2021
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.
Per MANTA VCD Instructions for Use (IFU)
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Netherlands3 sites
OLVG
Amsterdam
Catharina Ziekenhuis
Eindhoven
Erasmus Medical Center
Rotterdam
About this study
Official title: Post-Market Clinical Registry to Evaluate the Safety and Performance of MANTA Vascular Closure Device (VCD) Under Real World Conditions in the European Union (EU)
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.
- Conditions
- Femoral Arteriotomy Closure
- Being tested
- CE-marked MANTA vascular closure device (VCD)
- Keywords
- 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.
CE-marked MANTA vascular closure device (VCD)Device
Compile real word data on MANTA VCD.
| Study group | Role | What they receive |
|---|---|---|
| CE-marked MANTA vascular closure devices per IFU | Transcatheter Aortic Valve Replacement (TAVR), Endovascular aneurysm repair (EVAR), TEVAR, etc. Receives: Device: CE-marked MANTA vascular closure device (VCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Hemostasis
The elapsed time between MANTA deployment (withdrawal of sheath from artery) and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).
Measured: Immediately after deployment of MANTA VCD
Number of Participants With One or More Major Access Site Related Complications
Major access site related complications adapted from the VARC-2 definitions
Measured: within 30 days of procedure
Secondary outcomes (1)
Number of Participants With One or More Minor Access Site Related Complications
Minor access site related complications adapted from the VARC-2 definitions
Measured: within 30 days of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start23 Feb 2018
- Primary completion8 Aug 2019
- Study completion1 Feb 2021
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 500 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Essential Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Van Mieghem, MD, Principal investigator, Erasmus Medical Center Rotterdam Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330002
- Sponsor's protocol ID
- PSD-212
- Acronym
- MARVEL
- Status last verified
- Apr 2021
- First submitted
- 31 Oct 2017
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Not yet decided
Publications
Kadakia MB, Herrmann HC, Desai ND, Fox Z, Ogbara J, Anwaruddin S, Jagasia D, Bavaria JE, Szeto WY, Vallabhajosyula P, Li R, Menon R, Kobrin DM, Giri J. Factors associated with vascular complications in patients undergoing balloon-expandable transfemoral transcatheter aortic valve replacement via open versus percutaneous approaches. Circ Cardiovasc Interv. 2014 Aug;7(4):570-6. doi: 10.1161/CIRCINTERVENTIONS.113.001030. Epub 2014 Jul 15.
PubMed 25027520Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1.
PubMed 23026738
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Registry to Evaluate the Safety and Performance of MANTA Vascular Closure Device (VCD) Under Real World Conditions in the European Union (EU)
- ClinicalTrials.gov ID
- NCT03330002
- Acronym / sponsor ID
- MARVEL / PSD-212
- Conditions
- Femoral Arteriotomy Closure
- Keywords
- Arterial Closure Device, Large Bore Closure Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Essential Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 5 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CE-marked MANTA vascular closure devices per IFU | – | Device: CE-marked MANTA vascular closure device (VCD)Transcatheter Aortic Valve Replacement (TAVR), Endovascular aneurysm repair (EVAR), TEVAR, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.
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 |
|---|---|---|
| CE-marked MANTA vascular closure device (VCD)Compile real word data on MANTA VCD. | Device | CE-marked MANTA vascular closure devices per IFU |
Primary outcome
Time to Hemostasis
Time frame: Immediately after deployment of MANTA VCD
The elapsed time between MANTA deployment (withdrawal of sheath from artery) and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).
Number of Participants With One or More Major Access Site Related Complications
Time frame: within 30 days of procedure
Major access site related complications adapted from the VARC-2 definitions
1 secondary outcome
Number of Participants With One or More Minor Access Site Related Complications
Time frame: within 30 days of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25027520Kadakia MB, Herrmann HC, Desai ND, Fox Z, Ogbara J, Anwaruddin S, Jagasia D, Bavaria JE, Szeto WY, Vallabhajosyula P, Li R, Menon R, Kobrin DM, Giri J. Factors associated with vascular complications in patients undergoing balloon-expandable transfemoral transcatheter aortic valve replacement via open versus percutaneous approaches. Circ Cardiovasc Interv. 2014 Aug;7(4):570-6. doi: 10.1161/CIRCINTERVENTIONS.113.001030. Epub 2014 Jul 15.
- Background: PubMed 23026738Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1.
- Individual participant dataSharing planned: Undecided. Not yet decided
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.
Nicolas Van Mieghem, MD principal investigator
Erasmus Medical Center Rotterdam Netherlands
9 sites in 5 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 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands, Canada, Finland, Denmark, Switzerland. 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 5 May 2021). 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?
Time to Hemostasis (time frame: Immediately after deployment of MANTA VCD). 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?
On the ClinicalTrials.gov record for NCT03330002, which also lists 2 linked publications.
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 5 May 2021.