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MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study (SAFE_MANTA)

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
Sponsor:
Information provided by (Responsible Party):
Essential Medical, Inc.

Study Description
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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

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
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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
Arms and Interventions
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Arm Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  1. 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)
  2. 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
  3. Eligible for sheath removal in the catheterization lab
  4. Age ≥21 years
  5. Understand and sign the study specific written informed consent form
  6. Able and willing to fulfill the follow-up requirements
  7. 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:

  1. Known to be pregnant or lactating
  2. Immunocompromised or with pre-existing autoimmune disease
  3. Systemic infection or a local infection at or near the access site
  4. Significant anemia (hemoglobin <10 g/DL, hematocrit <30%)
  5. Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2)
  6. Known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
  7. Allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
  8. Femoral artery puncture in target groin within the prior 14 days
  9. Previous iliofemoral intervention in region of access site, including but not limited to prior atherectomy, stenting, surgical or grafting procedures in the access area
  10. Patients who have undergone use of an intra-aortic balloon pump through the arterial access site within 30 days prior to the baseline evaluation
  11. Patients who are not mobile and are confined to a wheelchair or bed
  12. NYHA class IV heart failure
  13. Patients who have already participated in the IDE study
  14. Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period
  15. 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
Contacts and Locations
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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
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Sponsors and Collaborators
Essential Medical, Inc.
Investigators
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Principal Investigator: David Wood, MD St. Paul's Hospital
Principal Investigator: Zvonimir Krajcer, MD St. Luke's Episcopal
  Study Documents (Full-Text)

Documents provided by Essential Medical, Inc.:
Study Protocol  [PDF] June 2, 2017
Statistical Analysis Plan  [PDF] February 6, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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.
Keywords provided by Essential Medical, Inc.:
MANTA
Arterial Closure Device
Large Bore Closure Device