Clinical trial NCT02908880: MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study
Official title: Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Arteriotomy Closure
Keywords: MANTA
Arterial Closure Device
Large Bore Closure Device
Lead sponsor: Essential Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-21
Enrollment: 263
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Time to Hemostasis
timeFrame: During access site closure, usually within an hour of starting the procedure.
measure: Number of Patients With Major Complications, Within 30 Days of Procedure
timeFrame: Up to 30 days after procedure
Secondary outcomes:
measure: Technical Success
timeFrame: Within 6 hours after deployment of the MANTA device
measure: Number of Patients With VARC-2 Major Vascular Complications, Adapted From the VARC-2 Criteria, Within 30 Days of Procedure
timeFrame: Up to 30 days after procedure
measure: Number of Patients With Minor Complications, Within 30 Days of Procedure
timeFrame: Up to 30 days after procedure
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego VA Medical Center
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center
state: Indiana
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Kansas City
country: United States
facility: St. Luke Hospital (Mid America Heart)
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Heart Group
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Heart Hospital
state: South Dakota
city: Kingsport
country: United States
facility: Wellmont Holston Valley Hospital
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: St. Luke's Hospital - Texas Heart
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Charleston
country: United States
facility: CAMC Memorial Hospital
state: West Virginia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: St. Paul's Hospital
name: David Wood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Episcopal
name: Zvonimir Krajcer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.