Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    nct02908880
Previous Study | Return to List | Next Study

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.

Tracking Information
First Submitted Date  ICMJE September 9, 2016
First Posted Date  ICMJE September 21, 2016
Results First Submitted Date  ICMJE April 12, 2019
Results First Posted Date  ICMJE May 7, 2019
Last Update Posted Date September 25, 2019
Study Start Date  ICMJE December 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
Time to Hemostasis [ Time Frame: From time of MANTA sheath withdrawal until confirmed hemostasis which is approximately 10 minutes. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study
Official Title  ICMJE Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Femoral Arteriotomy Closure
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: MANTA vascular closure device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2016)
263
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02908880
Other Study ID Numbers  ICMJE PSD-109
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Essential Medical, Inc.
Study Sponsor  ICMJE Essential Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Wood, MD St. Paul's Hospital
Principal Investigator: Zvonimir Krajcer, MD St. Luke's Episcopal
PRS Account Essential Medical, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP