Trial Outcomes & Findings for MANTA Registry for Vascular Large-bore Closure (NCT NCT03330002)
NCT ID: NCT03330002
Last Updated: 2021-05-05
Results Overview
The elapsed time between MANTA deployment (withdrawal of sheath 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
Target enrollment
500 participants
Primary outcome timeframe
Immediately after deployment of MANTA VCD
Results posted on
2021-05-05
Participant Flow
Participant milestones
| Measure |
MANTA Vascular Closure Device (VCD)
MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
|
|---|---|
|
Overall Study
STARTED
|
500
|
|
Overall Study
COMPLETED
|
478
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
MANTA Vascular Closure Device (VCD)
MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Death
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MANTA Vascular Closure Device (VCD)
n=500 Participants
MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=500 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=500 Participants
|
|
Age, Categorical
>=65 years
|
491 Participants
n=500 Participants
|
|
Age, Continuous
|
80.8 years
STANDARD_DEVIATION 6.6 • n=500 Participants
|
|
Sex: Female, Male
Female
|
226 Participants
n=500 Participants
|
|
Sex: Female, Male
Male
|
274 Participants
n=500 Participants
|
|
Region of Enrollment
Canada
|
71 participants
n=500 Participants
|
|
Region of Enrollment
Netherlands
|
277 participants
n=500 Participants
|
|
Region of Enrollment
Finland
|
96 participants
n=500 Participants
|
|
Region of Enrollment
Denmark
|
29 participants
n=500 Participants
|
|
Region of Enrollment
Switzerland
|
27 participants
n=500 Participants
|
PRIMARY outcome
Timeframe: Immediately after deployment of MANTA VCDPopulation: Time to Hemostasis (TTH) was captured in 491/500 subject; 9 subjects did not have TTH recorded.
The elapsed time between MANTA deployment (withdrawal of sheath 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 (VCD)
n=491 Participants
MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
|
|---|---|
|
Time to Hemostasis
|
50 seconds
Interval 20.0 to 120.0
|
PRIMARY outcome
Timeframe: within 30 days of procedureMajor access site related complications adapted from the VARC-2 definitions
Outcome measures
| Measure |
MANTA Vascular Closure Device (VCD)
n=500 Participants
MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
|
|---|---|
|
Number of Participants With One or More Major Access Site Related Complications
|
20 Participants
|
SECONDARY outcome
Timeframe: within 30 days of procedureMinor access site related complications adapted from the VARC-2 definitions
Outcome measures
| Measure |
MANTA Vascular Closure Device (VCD)
n=500 Participants
MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
|
|---|---|
|
Number of Participants With One or More Minor Access Site Related Complications
|
29 Participants
|
Adverse Events
MANTA Vascular Closure Device (VCD)
Serious events: 110 serious events
Other events: 98 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
MANTA Vascular Closure Device (VCD)
n=500 participants at risk
MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Cardiac disorders
Atrioventricular block
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.40%
2/500 • Number of events 2 • Approximately 30 days after deployment of the MANTA device
|
|
Cardiac disorders
Bundle branch block left
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
5/500 • Number of events 5 • Approximately 30 days after deployment of the MANTA device
|
|
Cardiac disorders
Cardiac failure
|
0.40%
2/500 • Number of events 2 • Approximately 30 days after deployment of the MANTA device
|
|
Cardiac disorders
Cardiac tamponade
|
0.80%
4/500 • Number of events 4 • Approximately 30 days after deployment of the MANTA device
|
|
Cardiac disorders
Paravalvular aortic regurgitation
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Cardiac disorders
Pericardial effusion
|
0.40%
2/500 • Number of events 2 • Approximately 30 days after deployment of the MANTA device
|
|
Cardiac disorders
Ventricular tachycardia
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.60%
3/500 • Number of events 3 • Approximately 30 days after deployment of the MANTA device
|
|
Gastrointestinal disorders
Melaena
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
General disorders
Device embolisation
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
General disorders
Pyrexia
|
0.40%
2/500 • Number of events 2 • Approximately 30 days after deployment of the MANTA device
|
|
Immune system disorders
Drug hypersensitivity
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Infections and infestations
Gastroenteritis viral
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Infections and infestations
Pneumonia
|
1.2%
6/500 • Number of events 6 • Approximately 30 days after deployment of the MANTA device
|
|
Infections and infestations
Sepsis
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Infections and infestations
Vascular access site infection
|
0.40%
2/500 • Number of events 2 • Approximately 30 days after deployment of the MANTA device
|
|
Infections and infestations
Viral infection
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Fall
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
1.2%
6/500 • Number of events 6 • Approximately 30 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Vascular access site bleeding-oozing
|
3.4%
17/500 • Number of events 17 • Approximately 30 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Vascular access site occlusion
|
1.0%
5/500 • Number of events 5 • Approximately 30 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.0%
5/500 • Number of events 5 • Approximately 30 days after deployment of the MANTA device
|
|
Investigations
Haemoglobin decreased
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Investigations
Oxygen saturation decreased
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Nervous system disorders
Cerebrovascular accident
|
3.0%
15/500 • Number of events 15 • Approximately 30 days after deployment of the MANTA device
|
|
Nervous system disorders
Syncope
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Nervous system disorders
Transient ischaemic attack
|
0.60%
3/500 • Number of events 3 • Approximately 30 days after deployment of the MANTA device
|
|
Product Issues
Lead dislodgement
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Renal and urinary disorders
Acute kidney injury
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
7.2%
36/500 • Number of events 36 • Approximately 30 days after deployment of the MANTA device
|
|
Vascular disorders
Iliac artery perforation
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Vascular disorders
Peripheral artery dissection
|
0.60%
3/500 • Number of events 3 • Approximately 30 days after deployment of the MANTA device
|
|
Vascular disorders
Peripheral artery stenosis
|
0.40%
2/500 • Number of events 2 • Approximately 30 days after deployment of the MANTA device
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.20%
1/500 • Number of events 1 • Approximately 30 days after deployment of the MANTA device
|
|
Vascular disorders
Peripheral embolism
|
0.40%
2/500 • Number of events 2 • Approximately 30 days after deployment of the MANTA device
|
|
Vascular disorders
Vessel perforation
|
0.80%
4/500 • Number of events 4 • Approximately 30 days after deployment of the MANTA device
|
Other adverse events
| Measure |
MANTA Vascular Closure Device (VCD)
n=500 participants at risk
MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices.
|
|---|---|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
7.6%
38/500 • Number of events 38 • Approximately 30 days after deployment of the MANTA device
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
14.0%
70/500 • Number of events 70 • Approximately 30 days after deployment of the MANTA device
|
Additional Information
Darra Bigelow, Clinical Trials Manager
Essential Medical, a wholly owned subsidiary of Teleflex, Inc.
Phone: 610-331-7299
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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 multicenter 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