Trial Outcomes & Findings for MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study (NCT NCT02908880)
NCT ID: NCT02908880
Last Updated: 2019-09-25
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
263 participants
Primary outcome timeframe
During access site closure, usually within an hour of starting the procedure.
Results posted on
2019-09-25
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
263
|
|
Overall Study
COMPLETED
|
236
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Explantation of the device
|
1
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
Death
|
5
|
Baseline Characteristics
MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study
Baseline characteristics by cohort
| Measure |
MANTA Vascular Closure Device
n=263 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
254 Participants
n=93 Participants
|
|
Age, Continuous
|
79.4 years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
170 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
247 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
247 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Ankle Brachial Index (ABI)
|
1.1 ratio
STANDARD_DEVIATION 0.3 • n=93 Participants
|
|
Body Mass Index (BMI)
|
28.6 kg/m^2
STANDARD_DEVIATION 4.4 • n=93 Participants
|
|
Minimum Target Vessel Diameter
|
7.9 mm
STANDARD_DEVIATION 1.4 • n=93 Participants
|
|
Creatinine
|
97.1 umol/L
STANDARD_DEVIATION 27.7 • n=93 Participants
|
|
Hematocrit
|
0.39 L/L
STANDARD_DEVIATION 0.04 • n=93 Participants
|
|
Hemoglobin
|
8.1 mmol/L
STANDARD_DEVIATION 0.9 • n=93 Participants
|
|
Platelets
|
199.1 10^9/L
STANDARD_DEVIATION 63 • n=93 Participants
|
PRIMARY outcome
Timeframe: During access site closure, usually within an hour of starting the procedure.Population: Primary Analysis Cohort
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).
Outcome measures
| Measure |
MANTA Vascular Closure Device
n=263 Participants
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.
|
|---|---|
|
Time to Hemostasis
|
65.4 seconds
Standard Deviation 157.8
|
PRIMARY outcome
Timeframe: Up to 30 days after procedurePopulation: Primary Analysis Cohort
IDE Protocol-Defined Major Complications analyzed on a per-patient basis
Outcome measures
| Measure |
MANTA Vascular Closure Device
n=263 Participants
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.
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|---|---|
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Number of Patients With Major Complications, Within 30 Days of Procedure
|
14 Participants
|
SECONDARY outcome
Timeframe: Within 6 hours after deployment of the MANTA devicePopulation: Primary Analysis Cohort
Percutaneous vascular closure obtained with the MANTA device without the use of unplanned endovascular or surgical intervention
Outcome measures
| Measure |
MANTA Vascular Closure Device
n=263 Participants
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.
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|---|---|
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Technical Success
|
257 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after procedurePopulation: Primary Analysis Cohort
Incidence of VARC-2 Major Vascular Complications, analyzed on a per-patient basis
Outcome measures
| Measure |
MANTA Vascular Closure Device
n=263 Participants
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.
|
|---|---|
|
Number of Patients With VARC-2 Major Vascular Complications, Adapted From the VARC-2 Criteria, Within 30 Days of Procedure
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after procedurePopulation: Primary Analysis Cohort
Incidence of IDE Protocol-defined Minor Complications, analyzed on a per-patient analysis
Outcome measures
| Measure |
MANTA Vascular Closure Device
n=263 Participants
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.
|
|---|---|
|
Number of Patients With Minor Complications, Within 30 Days of Procedure
|
7 Participants
|
Adverse Events
MANTA Vascular Closure Device
Serious events: 70 serious events
Other events: 71 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
MANTA Vascular Closure Device
n=263 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
5/263 • Approximately 60 days after deployment of the MANTA device
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Blood and lymphatic system disorders
Mild leukocytosis of non study leg
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Bradycardia
|
0.76%
2/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Complete Heart Block
|
2.7%
7/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Pericardial effusion
|
0.76%
2/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Heart Block
|
1.5%
4/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Congestive Heart Failure Exacerbation
|
1.9%
5/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Cardiogenic Shock
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Atrial Fibrillation
|
1.1%
3/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Left Bundle Branch Block
|
0.76%
2/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Thrombus
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Sinus arrest
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
AV Nodal Conduction Disorder
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Atrial Flutter
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Arrhythmia not otherwise noted
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Cardiac disorders
Acute Cardiac Failure
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Gastrointestinal disorders
Severe Gastritis
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Gastrointestinal disorders
Retroperitoneal bleed
|
0.76%
2/263 • Approximately 60 days after deployment of the MANTA device
|
|
Gastrointestinal disorders
Ischemic Bowel
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
General disorders
Fever
|
0.76%
2/263 • Approximately 60 days after deployment of the MANTA device
|
|
General disorders
Abnormal Gait
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Infections and infestations
Urinary Tract Infection
|
0.76%
2/263 • Approximately 60 days after deployment of the MANTA device
|
|
Infections and infestations
Septic Shock
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Infections and infestations
Pneumonia
|
0.76%
2/263 • Approximately 60 days after deployment of the MANTA device
|
|
Infections and infestations
Sepsis
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Infections and infestations
Systemic Infection
|
0.76%
2/263 • Approximately 60 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Access site bleeding-arterial
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Valve thrombosis or patient prothesis mismatch
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
1.5%
4/263 • Approximately 60 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Access site Occlusion
|
1.9%
5/263 • Approximately 60 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Multiple falls with prolonged immobilization
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Investigations
Decrease in Ejection Fraction
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Investigations
Local infection at location other than femoral access sites
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Metabolism and nutrition disorders
Acute gout on left knee
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Musculoskeletal and connective tissue disorders
PPM pocket hematoma
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Musculoskeletal and connective tissue disorders
Left arm and shoulder pain
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent lymphoma
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Nervous system disorders
Vaso-vagal Event
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Nervous system disorders
Acute Aphasia
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Nervous system disorders
Stroke/cerebrovascular accident
|
1.1%
3/263 • Approximately 60 days after deployment of the MANTA device
|
|
Nervous system disorders
Intraparenchymal Hemorrhage in left frontal lobe
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Nervous system disorders
Hemorrhage within horizontal sylvian fissure on left and intraventricular hemorrhage
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Nervous system disorders
Acute Metabolic Encephalopathy
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Nervous system disorders
Transient ischemic attack
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Product Issues
Decreased cardiac functional status
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Renal and urinary disorders
Acute urinary retention post TAVI
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Renal and urinary disorders
Urinary Retention
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Renal and urinary disorders
Renal Failure
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
1.5%
4/263 • Approximately 60 days after deployment of the MANTA device
|
|
Respiratory, thoracic and mediastinal disorders
Acute Dyspnea
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Respiratory, thoracic and mediastinal disorders
Right lower lobe pulmonary embolism
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Vascular disorders
Femoral artery stenosis
|
0.76%
2/263 • Approximately 60 days after deployment of the MANTA device
|
|
Vascular disorders
Retrograde dissection originating at puncture site
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Vascular disorders
Distal External Iliact Artery Stenosis >50%
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Vascular disorders
Limb ischemia
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Vascular disorders
Hypotension
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Vascular disorders
Hypovolemic shock
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Vascular disorders
NSTEMI
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Vascular disorders
Arterial embolism to limb
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
|
Vascular disorders
Type A Aortic dissection
|
0.76%
2/263 • Approximately 60 days after deployment of the MANTA device
|
|
Vascular disorders
Left Arm Hematoma
|
0.38%
1/263 • Approximately 60 days after deployment of the MANTA device
|
Other adverse events
| Measure |
MANTA Vascular Closure Device
n=263 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Left Bundle Branch Block
|
5.3%
14/263 • Approximately 60 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Access site bleeding-oozing
|
14.8%
39/263 • Approximately 60 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Hematoma
|
11.0%
29/263 • Approximately 60 days after deployment of the MANTA device
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Typical language included: Research Institution and Principal Investigator agree that they shall not, without the Sponsor's prior written consent, independently Publish any results of or information about the activities conducted until the multi-center publication is released. If a multi-center manuscript is not submitted for publication within one (1) year after completion of the multi-center Study, Research Institution and Principal Investigator shall have the right to Publish results.
- Publication restrictions are in place
Restriction type: OTHER