MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

NCT02908880 | Completed Results DMC

• 1 other identifier: PSD-109
• Study Type: interventional
• Target: 263
• Locations: 2 countries
• Sites: 19

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.

Conditions

Femoral Arteriotomy Closure

Keywords

MANTA; Arterial Closure Device; Large Bore Closure Device

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Technical Success

  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

  Up to 30 days after procedure

• Number of Patients With Minor Complications, Within 30 Days of Procedure

  Up to 30 days after procedure

Study Arms (1)

MANTA vascular closure device

EXPERIMENTAL

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

Interventions

MANTA vascular closure device 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.

Also known as: MANTA

MANTA vascular closure device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Essential Medical, Inc.: lead

Study Sites (19)

San Diego VA Medical Center

San Diego, California, 92161, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

St. Vincent Heart Center

Indianapolis, Indiana, 46290, United States

Location

Henry Ford

Detroit, Michigan, 48202, United States

Location

St. Luke Hospital (Mid America Heart)

Kansas City, Missouri, 64111, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Lankenau Heart Group

Wynnewood, Pennsylvania, 19096, United States

Location

Avera Heart Hospital

Sioux Falls, South Dakota, 57108, United States

Location

Wellmont Holston Valley Hospital

Kingsport, Tennessee, 37660, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

St. Luke's Hospital - Texas Heart

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

CAMC Memorial Hospital

Charleston, West Virginia, 25304, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (2)

• 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.

  PMID: 32193971 DERIVED

• 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.

  PMID: 31296082 DERIVED

Results Point of Contact

• Title: Sam Nardone
• Organization: Essential Medical, Inc.

sam@essmedclosure.com

6105571009

Study Officials

• David Wood, MD

  St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

• Zvonimir Krajcer, MD

  St. Luke's Episcopal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 21, 2016
• Study Start: December 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 25, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

US (18); CA (1)