Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    nct02908880
Previous Study | Return to List | Next Study

MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study (SAFE_MANTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02908880
Recruitment Status : Completed
First Posted : September 21, 2016
Results First Posted : May 7, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Essential Medical, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Femoral Arteriotomy Closure
Intervention Device: MANTA vascular closure device
Enrollment 263
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MANTA Vascular Closure Device
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 263 [1]
Completed 236 [2]
Not Completed 27
Reason Not Completed
Lost to Follow-up             4
Explantation of the device             1
Withdrawal by Subject             17
Death             5
[1]
Subjects within the Primary Analysis Cohort that received the MANTA Device
[2]
Subjects within the Primary Analysis Cohort that completed all follow-up time points.
Arm/Group Title MANTA Vascular Closure Device
Hide Arm/Group Description

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 Number of Baseline Participants 263
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
   3.4%
>=65 years
254
  96.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 263 participants
79.4  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants
Female
93
  35.4%
Male
170
  64.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants
Hispanic or Latino
16
   6.1%
Not Hispanic or Latino
247
  93.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants
American Indian or Alaska Native
0
   0.0%
Asian
7
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
   3.0%
White
247
  93.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   0.4%
Ankle Brachial Index (ABI)  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 263 participants
1.1  (0.3)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 263 participants
28.6  (4.4)
Minimum Target Vessel Diameter  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 263 participants
7.9  (1.4)
Creatinine  
Mean (Standard Deviation)
Unit of measure:  umol/L
Number Analyzed 263 participants
97.1  (27.7)
Hematocrit  
Mean (Standard Deviation)
Unit of measure:  L/L
Number Analyzed 263 participants
0.39  (0.04)
Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 263 participants
8.1  (0.9)
Platelets  
Mean (Standard Deviation)
Unit of measure:  10^9/L
Number Analyzed 263 participants
199.1  (63)
1.Primary Outcome
Title Time to Hemostasis
Hide Description 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).
Time Frame During access site closure, usually within an hour of starting the procedure.
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Cohort
Arm/Group Title MANTA Vascular Closure Device
Hide Arm/Group Description:

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 Number of Participants Analyzed 263
Mean (Standard Deviation)
Unit of Measure: seconds
65.4  (157.8)
2.Primary Outcome
Title Number of Patients With Major Complications, Within 30 Days of Procedure
Hide Description IDE Protocol-Defined Major Complications analyzed on a per-patient basis
Time Frame Up to 30 days after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Cohort
Arm/Group Title MANTA Vascular Closure Device
Hide Arm/Group Description:

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 Number of Participants Analyzed 263
Measure Type: Count of Participants
Unit of Measure: Participants
14
   5.3%
3.Secondary Outcome
Title Technical Success
Hide Description Percutaneous vascular closure obtained with the MANTA device without the use of unplanned endovascular or surgical intervention
Time Frame Within 6 hours after deployment of the MANTA device
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Cohort
Arm/Group Title MANTA Vascular Closure Device
Hide Arm/Group Description:

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 Number of Participants Analyzed 263
Measure Type: Count of Participants
Unit of Measure: Participants
257
  97.7%
4.Secondary Outcome
Title Number of Patients With VARC-2 Major Vascular Complications, Adapted From the VARC-2 Criteria, Within 30 Days of Procedure
Hide Description Incidence of VARC-2 Major Vascular Complications, analyzed on a per-patient basis
Time Frame Up to 30 days after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Cohort
Arm/Group Title MANTA Vascular Closure Device
Hide Arm/Group Description:

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 Number of Participants Analyzed 263
Measure Type: Count of Participants
Unit of Measure: Participants
11
   4.2%
5.Secondary Outcome
Title Number of Patients With Minor Complications, Within 30 Days of Procedure
Hide Description Incidence of IDE Protocol-defined Minor Complications, analyzed on a per-patient analysis
Time Frame Up to 30 days after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Cohort
Arm/Group Title MANTA Vascular Closure Device
Hide Arm/Group Description:

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 Number of Participants Analyzed 263
Measure Type: Count of Participants
Unit of Measure: Participants
7
   2.7%
Time Frame Approximately 60 days after deployment of the MANTA device
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MANTA Vascular Closure Device
Hide Arm/Group Description

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.

All-Cause Mortality
MANTA Vascular Closure Device
Affected / at Risk (%)
Total   5/263 (1.90%) 
Hide Serious Adverse Events
MANTA Vascular Closure Device
Affected / at Risk (%)
Total   70/263 (26.62%) 
Blood and lymphatic system disorders   
Anemia   5/263 (1.90%) 
Thrombocytopenia   1/263 (0.38%) 
Mild leukocytosis of non study leg   1/263 (0.38%) 
Cardiac disorders   
Bradycardia   2/263 (0.76%) 
Complete Heart Block   7/263 (2.66%) 
Pericardial effusion   2/263 (0.76%) 
Heart Block   4/263 (1.52%) 
Congestive Heart Failure Exacerbation   5/263 (1.90%) 
Cardiogenic Shock   1/263 (0.38%) 
Atrial Fibrillation   3/263 (1.14%) 
Left Bundle Branch Block   2/263 (0.76%) 
Thrombus   1/263 (0.38%) 
Sinus arrest   1/263 (0.38%) 
AV Nodal Conduction Disorder   1/263 (0.38%) 
Atrial Flutter   1/263 (0.38%) 
Arrhythmia not otherwise noted   1/263 (0.38%) 
Acute Cardiac Failure   1/263 (0.38%) 
Gastrointestinal disorders   
Severe Gastritis   1/263 (0.38%) 
Retroperitoneal bleed   2/263 (0.76%) 
Ischemic Bowel   1/263 (0.38%) 
Abdominal Pain   1/263 (0.38%) 
General disorders   
Fever   2/263 (0.76%) 
Abnormal Gait   1/263 (0.38%) 
Infections and infestations   
Urinary Tract Infection   2/263 (0.76%) 
Septic Shock   1/263 (0.38%) 
Pneumonia   2/263 (0.76%) 
Sepsis   1/263 (0.38%) 
Systemic Infection   2/263 (0.76%) 
Injury, poisoning and procedural complications   
Access site bleeding-arterial   1/263 (0.38%) 
Valve thrombosis or patient prothesis mismatch   1/263 (0.38%) 
Pseudoaneurysm   4/263 (1.52%) 
Access site Occlusion   5/263 (1.90%) 
Multiple falls with prolonged immobilization   1/263 (0.38%) 
Investigations   
Decrease in Ejection Fraction   1/263 (0.38%) 
Local infection at location other than femoral access sites   1/263 (0.38%) 
Metabolism and nutrition disorders   
Acute gout on left knee   1/263 (0.38%) 
Hyponatremia   1/263 (0.38%) 
Musculoskeletal and connective tissue disorders   
PPM pocket hematoma   1/263 (0.38%) 
Left arm and shoulder pain   1/263 (0.38%) 
Rhabdomyolysis   1/263 (0.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Recurrent lymphoma   1/263 (0.38%) 
Nervous system disorders   
Vaso-vagal Event   1/263 (0.38%) 
Acute Aphasia   1/263 (0.38%) 
Stroke/cerebrovascular accident   3/263 (1.14%) 
Intraparenchymal Hemorrhage in left frontal lobe   1/263 (0.38%) 
Hemorrhage within horizontal sylvian fissure on left and intraventricular hemorrhage   1/263 (0.38%) 
Acute Metabolic Encephalopathy   1/263 (0.38%) 
Transient ischemic attack   1/263 (0.38%) 
Product Issues   
Decreased cardiac functional status   1/263 (0.38%) 
Renal and urinary disorders   
Acute urinary retention post TAVI   1/263 (0.38%) 
Acute Kidney Injury   1/263 (0.38%) 
Urinary Retention   1/263 (0.38%) 
Renal Failure   1/263 (0.38%) 
Respiratory, thoracic and mediastinal disorders   
COPD Exacerbation   4/263 (1.52%) 
Acute Dyspnea   1/263 (0.38%) 
Shortness of Breath   1/263 (0.38%) 
Right lower lobe pulmonary embolism   1/263 (0.38%) 
Respiratory Failure   1/263 (0.38%) 
Pulmonary Edema   1/263 (0.38%) 
Vascular disorders   
Femoral artery stenosis   2/263 (0.76%) 
Retrograde dissection originating at puncture site   1/263 (0.38%) 
Distal External Iliact Artery Stenosis >50%   1/263 (0.38%) 
Limb ischemia   1/263 (0.38%) 
Hypotension   1/263 (0.38%) 
Hypovolemic shock   1/263 (0.38%) 
NSTEMI   1/263 (0.38%) 
Arterial embolism to limb   1/263 (0.38%) 
Type A Aortic dissection   2/263 (0.76%) 
Left Arm Hematoma   1/263 (0.38%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MANTA Vascular Closure Device
Affected / at Risk (%)
Total   71/263 (27.00%) 
Cardiac disorders   
Left Bundle Branch Block   14/263 (5.32%) 
Injury, poisoning and procedural complications   
Access site bleeding-oozing   39/263 (14.83%) 
Hematoma   29/263 (11.03%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sam Nardone
Organization: Essential Medical, Inc.
Phone: 6105571009
EMail: sam@essmedclosure.com
Layout table for additonal information
Responsible Party: Essential Medical, Inc.
ClinicalTrials.gov Identifier: NCT02908880    
Other Study ID Numbers: PSD-109
First Submitted: September 9, 2016
First Posted: September 21, 2016
Results First Submitted: April 12, 2019
Results First Posted: May 7, 2019
Last Update Posted: September 25, 2019