MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

NCT ID: NCT02908880

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-12-31

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.

Conditions

Femoral Arteriotomy Closure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MANTA vascular closure device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

MANTA

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Essential Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wood, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital

Zvonimir Krajcer, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Episcopal

Locations

San Diego VA Medical Center

San Diego, California, United States

Washington Hospital Center

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

Evanston Hospital

Evanston, Illinois, United States

St. Vincent Heart Center

Indianapolis, Indiana, United States

Henry Ford

Detroit, Michigan, United States

St. Luke Hospital (Mid America Heart)

Kansas City, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Hershey Medical Center

Hershey, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Lankenau Heart Group

Wynnewood, Pennsylvania, United States

Avera Heart Hospital

Sioux Falls, South Dakota, United States

Wellmont Holston Valley Hospital

Kingsport, Tennessee, United States

Houston Methodist

Houston, Texas, United States

St. Luke's Hospital - Texas Heart

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

CAMC Memorial Hospital

Charleston, West Virginia, United States

St. Paul's Hospital

Vancouver, British Columbia, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 32193971 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31296082 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PSD-109

Identifier Type: -

Identifier Source: org_study_id