MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study (SAFE_MANTA)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02908880 |
Recruitment Status :
Completed
First Posted : September 21, 2016
Results First Posted : May 7, 2019
Last Update Posted : September 25, 2019
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Condition or disease | Intervention/treatment | Phase |
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Femoral Arteriotomy Closure | Device: MANTA vascular closure device | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 263 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device |
Study Start Date : | December 2016 |
Actual Primary Completion Date : | October 2017 |
Actual Study Completion Date : | December 2017 |
Arm | Intervention/treatment |
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Experimental: MANTA vascular closure device
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.
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Device: MANTA vascular closure device
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.
Other Name: MANTA |
- 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
- Technical Success [ Time Frame: Within 6 hours after deployment of the MANTA device ]Percutaneous vascular closure obtained with the MANTA device without the use of unplanned endovascular or surgical intervention
- 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 ]Incidence of VARC-2 Major Vascular Complications, analyzed on a per-patient basis
- Number of Patients With Minor Complications, Within 30 Days of Procedure [ Time Frame: Up to 30 days after procedure ]Incidence of IDE Protocol-defined Minor Complications, analyzed on a per-patient analysis

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908880

Principal Investigator: | David Wood, MD | St. Paul's Hospital | |
Principal Investigator: | Zvonimir Krajcer, MD | St. Luke's Episcopal |
Documents provided by Essential Medical, Inc.:
Responsible Party: | Essential Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT02908880 |
Other Study ID Numbers: |
PSD-109 |
First Posted: | September 21, 2016 Key Record Dates |
Results First Posted: | May 7, 2019 |
Last Update Posted: | September 25, 2019 |
Last Verified: | September 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
MANTA Arterial Closure Device Large Bore Closure Device |