Femoral Arteriotomy ClosureSAFE_MANTANCT02908880
MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study
A study testing MANTA vascular closure device in people with Femoral Arteriotomy Closure, run by Essential Medical, Inc. at 19 sites in 2 countries.
Trial summary
Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. 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
- 263 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Dec 2016to Dec 2017
- 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 interventional procedure via a 10-18F size retrograde common femoral artery approach (i.e., transcatheter aortic valve implantation [TAVI], endovascular aneurysm repair [EVAR], Impella® use)
- Vessel size would allow for access for the MANTA device as determined by baseline CTA: minimum vessel diameter 5mm for the 14F MANTA and 6mm for the 18F MANTA
- Eligible for sheath removal in the catheterization lab
- Age ≥21 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, patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial
Who cannot join
- Known to be pregnant or lactating
- Immunocompromised or with pre-existing autoimmune disease
- Systemic infection or a local infection at or near the access site
- Significant anemia (hemoglobin <10 g/DL, hematocrit <30%)
- Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2)
- Known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
Show all 15Show fewer
- Allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
- Femoral artery puncture in target groin within the prior 14 days
- 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 who have undergone use of an intra-aortic balloon pump through the arterial access site within 30 days prior to the baseline evaluation
- Patients who are not mobile and are confined to a wheelchair or bed
- NYHA class IV heart failure
- Patients who have already participated in the IDE study
- Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period
- Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
CAMC Memorial Hospital
Charleston, West Virginia, 25304
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford
Detroit, Michigan, 48202
Evanston Hospital
Evanston, Illinois, 60201
Hershey Medical Center
Hershey, Pennsylvania, 17033
Houston Methodist
Houston, Texas, 77030
St. Luke's Hospital - Texas Heart
Houston, Texas, 77030
St. Vincent Heart Center
Indianapolis, Indiana, 46290
St. Luke Hospital (Mid America Heart)
Kansas City, Missouri, 64111
Wellmont Holston Valley Hospital
Kingsport, Tennessee, 37660
Columbia University Medical Center
New York, New York, 10032
Temple University Hospital
Philadelphia, Pennsylvania, 19140
The Heart Hospital Baylor Plano
Plano, Texas, 75093
San Diego VA Medical Center
San Diego, California, 92161
Swedish Medical Center
Seattle, Washington, 98122
Avera Heart Hospital
Sioux Falls, South Dakota, 57108
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Lankenau Heart Group
Wynnewood, Pennsylvania, 19096
About this study
Official title: Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device
Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.
Read the detailed description
The MANTA device is a 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 ID) interventional devices. The function of MANTA is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure.
The study is being conducted to demonstrate the safety and effectiveness of MANTA in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.
- 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
Also called MANTA
The appropriate size of MANTA closure device will be selected and used for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths.
| Study group | Role | What they receive |
|---|---|---|
| MANTA vascular closure device | Experimental | Open label, single arm study using the MANTA device, developed by Essential Medical, Inc. MANTA 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.
Time to Hemostasis
The elapsed time between withdrawal of MANTA sheath/device from artery and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).
Measured: During access site closure, usually within an hour of starting the procedure.
Number of Patients With Major Complications, Within 30 Days of Procedure
IDE Protocol-Defined Major Complications analyzed on a per-patient basis
Measured: Up to 30 days after procedure
Secondary outcomes (3)
Technical Success
Percutaneous vascular closure obtained with the MANTA device without the use of unplanned endovascular or surgical intervention
Measured: Within 6 hours after deployment of the MANTA device
Number of Patients With VARC-2 Major Vascular Complications, Adapted From the VARC-2 Criteria, Within 30 Days of Procedure
Incidence of VARC-2 Major Vascular Complications, analyzed on a per-patient basis
Measured: Up to 30 days after procedure
Number of Patients With Minor Complications, Within 30 Days of Procedure
Incidence of IDE Protocol-defined Minor Complications, analyzed on a per-patient analysis
Measured: Up to 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startDec 2016
- Primary completionOct 2017
- Study completionDec 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essential Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wood, MD, Principal investigator, St. Paul's HospitalZvonimir Krajcer, MD, Principal investigator, St. Luke's Episcopal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908880
- Sponsor's protocol ID
- PSD-109
- Acronym
- SAFE_MANTA
- Status last verified
- Sep 2019
- First submitted
- 9 Sep 2016
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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.
Publications
Krajcer Z, Wood DA, Strickman N, Bernardo N, Metzger C, Aziz M, Bacharach JM, Nanjundappa A, Campbell J, Lee JT, Dake MD, Lumsden A, Nardone S. Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures. J Endovasc Ther. 2020 Jun;27(3):414-420. doi: 10.1177/1526602820912224. Epub 2020 Mar 20.
PubMed 32193971Wood DA, Krajcer Z, Sathananthan J, Strickman N, Metzger C, Fearon W, Aziz M, Satler LF, Waksman R, Eng M, Kapadia S, Greenbaum A, Szerlip M, Heimansohn D, Sampson A, Coady P, Rodriguez R, Krishnaswamy A, Lee JT, Ben-Dor I, Moainie S, Kodali S, Chhatriwalla AK, Yadav P, O'Neill B, Kozak M, Bacharach JM, Feldman T, Guerrero M, Nanjundappa A, Bersin R, Zhang M, Potluri S, Barker C, Bernardo N, Lumsden A, Barleben A, Campbell J, Cohen DJ, Dake M, Brown D, Maor N, Nardone S, Lauck S, O'Neill WW, Webb JG; SAFE MANTA Study Investigators. Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device. Circ Cardiovasc Interv. 2019 Jul;12(7):e007258. doi: 10.1161/CIRCINTERVENTIONS.119.007258. Epub 2019 Jul 12.
PubMed 31296082
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device
- ClinicalTrials.gov ID
- NCT02908880
- Acronym / sponsor ID
- SAFE_MANTA / PSD-109
- Conditions
- Femoral Arteriotomy Closure
- Keywords
- MANTA, Arterial Closure Device, Large Bore Closure Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Essential Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Posted 7 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.
Detailed description
The MANTA device is a 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 ID) interventional devices. The function of MANTA is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure.
The study is being conducted to demonstrate the safety and effectiveness of MANTA in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.
Study design
- Primary purpose
- Other
- 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 deviceOpen label, single arm study using the MANTA device, developed by Essential Medical, Inc. MANTA 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
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure via a 10-18F size retrograde common femoral artery approach (i.e., transcatheter aortic valve implantation [TAVI], endovascular aneurysm repair [EVAR], Impella® use)
- Vessel size would allow for access for the MANTA device as determined by baseline CTA: minimum vessel diameter 5mm for the 14F MANTA and 6mm for the 18F MANTA
- Eligible for sheath removal in the catheterization lab
- Age ≥21 years
- Understand and sign the study specific written informed consent form
Key exclusion criteria (15 listed)
- Known to be pregnant or lactating
- Immunocompromised or with pre-existing autoimmune disease
- Systemic infection or a local infection at or near the access site
- Significant anemia (hemoglobin <10 g/DL, hematocrit <30%)
- Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2)
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 deviceAlso: MANTAThe appropriate size of MANTA closure device will be selected and used for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths. | Device | MANTA vascular closure device |
Primary outcome
Time to Hemostasis
Time frame: During access site closure, usually within an hour of starting the procedure.
The elapsed time between withdrawal of MANTA sheath/device from artery and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).
Number of Patients With Major Complications, Within 30 Days of Procedure
Time frame: Up to 30 days after procedure
IDE Protocol-Defined Major Complications analyzed on a per-patient basis
3 secondary outcomes
Technical Success
Time frame: Within 6 hours after deployment of the MANTA device
Number of Patients With VARC-2 Major Vascular Complications, Adapted From the VARC-2 Criteria, Within 30 Days of Procedure
Time frame: Up to 30 days after procedure
Number of Patients With Minor Complications, Within 30 Days of Procedure
Time frame: Up to 30 days after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32193971Krajcer Z, Wood DA, Strickman N, Bernardo N, Metzger C, Aziz M, Bacharach JM, Nanjundappa A, Campbell J, Lee JT, Dake MD, Lumsden A, Nardone S. Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures. J Endovasc Ther. 2020 Jun;27(3):414-420. doi: 10.1177/1526602820912224. Epub 2020 Mar 20.
- Derived from this study: PubMed 31296082Wood DA, Krajcer Z, Sathananthan J, Strickman N, Metzger C, Fearon W, Aziz M, Satler LF, Waksman R, Eng M, Kapadia S, Greenbaum A, Szerlip M, Heimansohn D, Sampson A, Coady P, Rodriguez R, Krishnaswamy A, Lee JT, Ben-Dor I, Moainie S, Kodali S, Chhatriwalla AK, Yadav P, O'Neill B, Kozak M, Bacharach JM, Feldman T, Guerrero M, Nanjundappa A, Bersin R, Zhang M, Potluri S, Barker C, Bernardo N, Lumsden A, Barleben A, Campbell J, Cohen DJ, Dake M, Brown D, Maor N, Nardone S, Lauck S, O'Neill WW, Webb JG; SAFE MANTA Study Investigators. Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device. Circ Cardiovasc Interv. 2019 Jul;12(7):e007258. doi: 10.1161/CIRCINTERVENTIONS.119.007258. Epub 2019 Jul 12.
- 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, MD principal investigator
St. Paul's Hospital
Zvonimir Krajcer, MD principal investigator
St. Luke's Episcopal
19 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 19 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 15 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 7 May 2019). 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: During access site closure, usually within an hour of starting 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 NCT02908880, 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 25 Sep 2019.