MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

Femoral Arteriotomy Closure Clinical Trial

— SAFE_MANTA  

Official title:

Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908880
• Other study ID #: PSD-109
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: September 2019
• Source: Essential Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Arteriotomy Closure

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	CAMC Memorial Hospital	Charleston	West Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford	Detroit	Michigan
United States	Evanston Hospital	Evanston	Illinois
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Houston Methodist	Houston	Texas
United States	St. Luke's Hospital - Texas Heart	Houston	Texas
United States	St. Vincent Heart Center	Indianapolis	Indiana
United States	St. Luke Hospital (Mid America Heart)	Kansas City	Missouri
United States	Wellmont Holston Valley Hospital	Kingsport	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	San Diego VA Medical Center	San Diego	California
United States	Swedish Medical Center	Seattle	Washington
United States	Avera Heart Hospital	Sioux Falls	South Dakota
United States	Washington Hospital Center	Washington	District of Columbia
United States	Lankenau Heart Group	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Essential Medical, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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
Secondary	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