Femoral Arteriotomy ClosureNCT02521948
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
A study testing MANTA Vascular Closure Device in people with Femoral Arteriotomy Closure, run by Essential Medical, Inc. at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite Europeenne--"European Conformity") and other regulatory… 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?
- MANTA Vascular Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2015to May 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for non-emergent transcatheter interventional procedure via a 10-18F femoral sheath (e.g., transcatheter aortic valve replacement [TAVR], balloon aortic valvuloplasty [BAV], Abdominal Aortic Aneurysm [AAA] stent-graft placement)
- Eligible for sheath removal in the catheterization lab
- Age ≥18 years
- Understand and sign the study specific written informed consent form
- Able and willing to fulfill the follow-up requirements
- In the Investigator's opinion, the patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial
- Patients of childbearing age with Negative Pregnancy Test within 7 days of procedure
Who cannot join
- Baseline Exclusions:
- Patients who are known to be pregnant or lactating
- Patients who are immunocompromised or with pre-existing autoimmune disease
- Patients who have a systemic infection or a local infection at or near the access site
- Patients requiring a re-puncture at a site previously punctured within 48 hours
- Patients with significant anemia (hemoglobin < 6.5 mmol/l, Hct<30)
Show all 25Show fewer
- Patients who are morbidly obese or cachectic (BMI >40 or <20)
- Patients with Systolic Blood Pressure >180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure
- Patients who are currently participating in another clinical trial of an investigational device or drug that has not concluded the follow-up period
- Patients in whom an antegrade puncture is performed or planned
- Patients with a known bleeding disorder including thrombocytopenia (platelet count <150 x 10^9/L), thrombasthenia, hemophilia, or von Willebrand's disease
- Patients with a femoral artery <6 mm in diameter, femoral artery stenosis resulting in a vessel diameter <6 mm, or patients with severe peripheral vascular disease
- Common femoral artery with fluoroscopically visible calcium, as determined by Angio CT, precluding safe access in the opinion of the investigator
- Patients with allergy to bovine materials, collagen and/or collagen products, or polyglycolic or polylactic acid polymers
- Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence or life threatening disease
- Patients with Sheehan Disability Scale (SDS) scores >12
- Patients punctured through a vascular graft
- Patients with known allergy to stainless steel or nickel
- Patients who have acute ST-elevation myocardial infarction within 48 hours prior to procedure
- Patients with unilateral or bilateral lower extremity amputation
- Patients with renal insufficiency (serum creatinine >2.5 mg/dl)
- Patients undergoing therapeutic thrombolysis
- Patients who are unable to ambulate at baseline
- Patients undergoing an interventional procedure whom are being treated with warfarin
- Patients requiring a continuous oral anticoagulation therapy
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites
St. Antonius Ziekenhuis
Nieuwegein
Erasmus Medical Center
Rotterdam
About this study
The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite Europeenne--"European Conformity") and other regulatory submissions. The study will assess whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after interventional procedures.
Read the detailed description
The purpose of this study is to evaluate the safety and performance of MANTA in achieving hemostasis in femoral arterial access sites in patients undergoing percutaneous transcatheter interventional procedures using a 10-18F procedure sheath (such as Transcather Aortic Valve Replacement (TAVR), Balloon Aortic Valvuloplasty (BAV) and Endovascular Aneurysm Repair (EVAR)) for purposes of obtaining a CE Mark in the European Union.
The study will evaluate hemostasis success, time to hemostasis and ambulation, treatment success, and the rate of access-site-related complications in comparison to published literature on other hemostasis techniques for closing these large bore punctures (primarily, surgical closure and suture-mediated percutaneous closure.
- 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 device developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
| Study group | Role | What they receive |
|---|---|---|
| MANTA Vascular Closure Device | Experimental | The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices. Receives: Device: MANTA Vascular Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Complications
Composite endpoint that includes any of the following adverse events:
- Access site-related bleeding requiring blood transfusion or vascular repair
- Vascular injury requiring repair (e.g. perforation, dissection, arterio-venous fistula, retroperitoneal bleed, pseudoaneurysm)
- Femoral artery stenosis at the access site requiring intervention
- New ipsilateral lower extremity ischemia causing a threat to the viability of the limb
- Access site-related infection requiring intravenous antibiotics and/or extended hospitalization
- New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair
- Permanent access site-related nerve injury (lasting>30 days)
Measured: Within either the first 30 days (plus or minus 7 days) after the procedure or the first 60 days (plus or minus 14 days) after the procedure
Hemostasis Success
Hemostasis at the puncture site within 10 minutes of cutting the MANTA suture without need for manual or mechanical compression and without later re-bleeding (trivial or subcutaneous oozing will not be considered bleeding; light finger pressure to control subcutaneous oozing will not be considered manual compression)
Measured: Within the first 10 minutes of cutting the MANTA suture
Secondary outcomes (1)
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: Time between MANTA deployment and first observed and confirmed arterial hemostasis up to ten (10) minutes after MANTA device is deployed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionMay 2016
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 (3)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essential Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521948
- Sponsor's protocol ID
- PSD-051
- Status last verified
- Feb 2018
- First submitted
- 7 Aug 2015
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ben-Dor I, Looser P, Bernardo N, Maluenda G, Torguson R, Xue Z, Lindsay J, Pichard AD, Satler LF, Waksman R. Comparison of closure strategies after balloon aortic valvuloplasty: suture mediated versus collagen based versus manual. Catheter Cardiovasc Interv. 2011 Jul 1;78(1):119-24. doi: 10.1002/ccd.22940.
PubMed 21681898Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, Jones P, Bacharach JM. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014 May;59(5):1181-93. doi: 10.1016/j.jvs.2013.10.101. Epub 2014 Jan 17.
PubMed 24440678Kadakia 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 25027520
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
- ClinicalTrials.gov ID
- NCT02521948
- Acronym / sponsor ID
- PSD-051
- Conditions
- Femoral Arteriotomy Closure
- Keywords
- MANTA, Arterial Closure Device, Large Bore Closure Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Essential Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 29 Oct 2018
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 performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite Europeenne--"European Conformity") and other regulatory submissions. The study will assess whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after interventional procedures.
Detailed description
The purpose of this study is to evaluate the safety and performance of MANTA in achieving hemostasis in femoral arterial access sites in patients undergoing percutaneous transcatheter interventional procedures using a 10-18F procedure sheath (such as Transcather Aortic Valve Replacement (TAVR), Balloon Aortic Valvuloplasty (BAV) and Endovascular Aneurysm Repair (EVAR)) for purposes of obtaining a CE Mark in the European Union.
The study will evaluate hemostasis success, time to hemostasis and ambulation, treatment success, and the rate of access-site-related complications in comparison to published literature on other hemostasis techniques for closing these large bore punctures (primarily, surgical closure and suture-mediated percutaneous closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MANTA Vascular Closure Device | Experimental | Device: MANTA Vascular Closure DeviceThe MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Candidate for non-emergent transcatheter interventional procedure via a 10-18F femoral sheath (e.g., transcatheter aortic valve replacement [TAVR], balloon aortic valvuloplasty [BAV], Abdominal Aortic Aneurysm [AAA] stent-graft placement)
- Eligible for sheath removal in the catheterization lab
- Age ≥18 years
- Understand and sign the study specific written informed consent form
- Able and willing to fulfill the follow-up requirements
Key exclusion criteria (25 listed)
- Patients who are known to be pregnant or lactating
- Patients who are immunocompromised or with pre-existing autoimmune disease
- Patients who have a systemic infection or a local infection at or near the access site
- Patients requiring a re-puncture at a site previously punctured within 48 hours
- Patients with significant anemia (hemoglobin < 6.5 mmol/l, Hct<30)
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 device developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices. | Device | MANTA Vascular Closure Device |
Primary outcome
Number of Participants With Major Complications
Time frame: Within either the first 30 days (plus or minus 7 days) after the procedure or the first 60 days (plus or minus 14 days) after the procedure
Composite endpoint that includes any of the following adverse events: * Access site-related bleeding requiring blood transfusion or vascular repair * Vascular injury requiring repair (e.g. perforation, dissection, arterio-venous fistula, retroperitoneal bleed, pseudoaneurysm) * Femoral artery stenosis at the access site requiring intervention * New ipsilateral lower extremity ischemia causing a threat to the viability of the limb * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization * New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair * Permanent access site-related nerve injury (lasting>30 days)
Hemostasis Success
Time frame: Within the first 10 minutes of cutting the MANTA suture
Hemostasis at the puncture site within 10 minutes of cutting the MANTA suture without need for manual or mechanical compression and without later re-bleeding (trivial or subcutaneous oozing will not be considered bleeding; light finger pressure to control subcutaneous oozing will not be considered manual compression)
1 secondary outcome
Time to Hemostasis
Time frame: Time between MANTA deployment and first observed and confirmed arterial hemostasis up to ten (10) minutes after MANTA device is deployed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21681898Ben-Dor I, Looser P, Bernardo N, Maluenda G, Torguson R, Xue Z, Lindsay J, Pichard AD, Satler LF, Waksman R. Comparison of closure strategies after balloon aortic valvuloplasty: suture mediated versus collagen based versus manual. Catheter Cardiovasc Interv. 2011 Jul 1;78(1):119-24. doi: 10.1002/ccd.22940.
- Background: PubMed 24440678Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, Jones P, Bacharach JM. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014 May;59(5):1181-93. doi: 10.1016/j.jvs.2013.10.101. Epub 2014 Jan 17.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 3 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 7 inclusion and 25 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Italy. 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 29 Oct 2018). 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?
Number of Participants With Major Complications (time frame: Within either the first 30 days (plus or minus 7 days) after the procedure or the first 60 days (plus or minus 14 days) after the 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?
On the ClinicalTrials.gov record for NCT02521948, which also lists 3 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 29 Oct 2018.