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

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.

Study Overview

• Status: Completed
• Conditions: Femoral Arteriotomy Closure
• Intervention / Treatment: Device: MANTA vascular closure device

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: Interventional
• Enrollment (Actual): 263
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • St. Paul's Hospital
• United States
  • California
    • San Diego, California, United States, 92161
      • San Diego VA Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke Hospital (Mid America Heart)
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Heart Group
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Avera Heart Hospital
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • Houston, Texas, United States, 77030
      • St. Luke's Hospital - Texas Heart
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: MANTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Hemostasis	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).	During access site closure, usually within an hour of starting the procedure.
Number of Patients With Major Complications, Within 30 Days of Procedure	IDE Protocol-Defined Major Complications analyzed on a per-patient basis	Up to 30 days after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Percutaneous vascular closure obtained with the MANTA device without the use of unplanned endovascular or surgical intervention	Within 6 hours after deployment of the MANTA device
Number of Patients With VARC-2 Major Vascular Complications, Adapted From the VARC-2 Criteria, Within 30 Days of Procedure	Incidence of VARC-2 Major Vascular Complications, analyzed on a per-patient basis	Up to 30 days after procedure
Number of Patients With Minor Complications, Within 30 Days of Procedure	Incidence of IDE Protocol-defined Minor Complications, analyzed on a per-patient analysis	Up to 30 days after procedure

Collaborators and Investigators

• Sponsor: Essential Medical, Inc.
• 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: December 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: MANTA; Arterial Closure Device; Large Bore Closure Device
• Other Study ID Numbers: PSD-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.