MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02908880

Acronym

SAFE_MANTA

Enrollment

263

Registered

2016-09-21

Start date

2016-12-31

Completion date

2017-12-31

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Arteriotomy Closure

Keywords

MANTA, Arterial Closure Device, Large Bore Closure Device

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.

Interventions

DEVICEMANTA 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada, United States

Participant flow

Participants by arm

Arm	Count
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. MANTA vascular closure device: The appropriate size of MANTA closure device will be selected and used to 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.	263
Total	263

Arm

Count

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. MANTA vascular closure device: The appropriate size of MANTA closure device will be selected and used to 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.

263

Total

263

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	5
Overall Study	Explantation of the device	1
Overall Study	Lost to Follow-up	4
Overall Study	Withdrawal by Subject	17

Baseline characteristics

Characteristic	MANTA Vascular Closure Device
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	254 Participants
Age, Categorical Between 18 and 65 years	9 Participants
Age, Continuous	79.4 years STANDARD_DEVIATION 8.4
Ankle Brachial Index (ABI)	1.1 ratio STANDARD_DEVIATION 0.3
Body Mass Index (BMI)	28.6 kg/m^2 STANDARD_DEVIATION 4.4
Creatinine	97.1 umol/L STANDARD_DEVIATION 27.7
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	247 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Hematocrit	0.39 L/L STANDARD_DEVIATION 0.04
Hemoglobin	8.1 mmol/L STANDARD_DEVIATION 0.9
Minimum Target Vessel Diameter	7.9 mm STANDARD_DEVIATION 1.4
Platelets	199.1 10^9/L STANDARD_DEVIATION 63
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	7 Participants
Race (NIH/OMB) Black or African American	8 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	247 Participants
Sex: Female, Male Female	93 Participants
Sex: Female, Male Male	170 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	5 / 263
other Total, other adverse events	71 / 263
serious Total, serious adverse events	70 / 263

Outcome results

Primary