- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02908880
MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study (SAFE_MANTA)
Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada
- St. Paul's Hospital
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California
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San Diego, California, United States, 92161
- San Diego VA Medical Center
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Hospital Center
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Illinois
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Evanston, Illinois, United States, 60201
- Evanston Hospital
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Indiana
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Indianapolis, Indiana, United States, 46290
- St. Vincent Heart Center
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford
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Missouri
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Kansas City, Missouri, United States, 64111
- St. Luke Hospital (Mid America Heart)
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19140
- Temple University Hospital
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Wynnewood, Pennsylvania, United States, 19096
- Lankenau Heart Group
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South Dakota
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Sioux Falls, South Dakota, United States, 57108
- Avera Heart Hospital
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Tennessee
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Kingsport, Tennessee, United States, 37660
- Wellmont Holston Valley Hospital
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Texas
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Houston, Texas, United States, 77030
- Houston Methodist
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Houston, Texas, United States, 77030
- St. Luke's Hospital - Texas Heart
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Plano, Texas, United States, 75093
- The Heart Hospital Baylor Plano
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Washington
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Seattle, Washington, United States, 98122
- Swedish Medical Center
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West Virginia
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Charleston, West Virginia, United States, 25304
- CAMC Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Hemostasis
Time Frame: During access site closure, usually within an hour of starting the procedure.
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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).
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During access site closure, usually within an hour of starting the procedure.
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Number of Patients With Major Complications, Within 30 Days of Procedure
Time Frame: Up to 30 days after procedure
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IDE Protocol-Defined Major Complications analyzed on a per-patient basis
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Up to 30 days after procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Technical Success
Time Frame: Within 6 hours after deployment of the MANTA device
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Percutaneous vascular closure obtained with the MANTA device without the use of unplanned endovascular or surgical intervention
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Within 6 hours after deployment of the MANTA device
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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
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Incidence of VARC-2 Major Vascular Complications, analyzed on a per-patient basis
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Up to 30 days after procedure
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Number of Patients With Minor Complications, Within 30 Days of Procedure
Time Frame: Up to 30 days after procedure
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Incidence of IDE Protocol-defined Minor Complications, analyzed on a per-patient analysis
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Up to 30 days after procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Wood, MD, St. Paul's Hospital
- Principal Investigator: Zvonimir Krajcer, MD, St. Luke's Episcopal
Publications and helpful links
General 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.
- Wood 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PSD-109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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