MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study (SAFE_MANTA)
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| ClinicalTrials.gov Identifier: NCT02908880 |
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Recruitment Status :
Completed
First Posted : September 21, 2016
Last Update Posted : April 27, 2018
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Sponsor:
Essential Medical, Inc.
Information provided by (Responsible Party):
Essential Medical, Inc.
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Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 o 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 |
| 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 : | September 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 to 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 |
Primary Outcome Measures :
- Time to Hemostasis [ Time Frame: Time of Procedure ]From time of MANTA sheath withdrawal until confirmed hemostasis which is approximately 10 minutes.
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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
Locations
| United States, California | |
| San Diego VA Medical Center | |
| San Diego, California, United States, 92161 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Illinois | |
| Evanston Hospital | |
| Evanston, Illinois, United States, 60201 | |
| United States, Indiana | |
| St. Vincent Heart Center | |
| Indianapolis, Indiana, United States, 46290 | |
| United States, Michigan | |
| Henry Ford | |
| Detroit, Michigan, United States, 48202 | |
| United States, Missouri | |
| St. Luke Hospital (Mid America Heart) | |
| Kansas City, Missouri, United States, 64111 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Lankenau Heart Group | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| United States, South Dakota | |
| Avera Heart Hospital | |
| Sioux Falls, South Dakota, United States, 57108 | |
| United States, Tennessee | |
| Wellmont Holston Valley Hospital | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| Houston Methodist | |
| Houston, Texas, United States, 77030 | |
| St. Luke's Hospital - Texas Heart | |
| Houston, Texas, United States, 77030 | |
| The Heart Hospital Baylor Plano | |
| Plano, Texas, United States, 75093 | |
| United States, Washington | |
| Swedish Medical Center | |
| Seattle, Washington, United States, 98122 | |
| United States, West Virginia | |
| CAMC Memorial Hospital | |
| Charleston, West Virginia, United States, 25304 | |
| Canada, British Columbia | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada | |
Sponsors and Collaborators
Essential Medical, Inc.
Investigators
| Principal Investigator: | David Wood, MD | St. Paul's Hospital | |
| Principal Investigator: | Zvonimir Krajcer, MD | St. Luke's Episcopal |
| Responsible Party: | Essential Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT02908880 History of Changes |
| Other Study ID Numbers: |
PSD-109 |
| First Posted: | September 21, 2016 Key Record Dates |
| Last Update Posted: | April 27, 2018 |
| Last Verified: | April 2018 |
| 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. |
Keywords provided by Essential Medical, Inc.:
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MANTA, arterial closure device, large bore closure device |