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The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CE-marked MANTA vascular closure devices per IFU | Transcatheter Aortic Valve Replacement (TAVR), Endovascular aneurysm repair (EVAR), TEVAR, etc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE-marked MANTA vascular closure device (VCD) | Device | Compile real word data on MANTA VCD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hemostasis | 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). | Immediately after deployment of MANTA VCD |
| Number of Participants With One or More Major Access Site Related Complications | Major access site related complications adapted from the VARC-2 definitions | within 30 days of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Minor Access Site Related Complications | Minor access site related complications adapted from the VARC-2 definitions | within 30 days of procedure |
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Per MANTA VCD Instructions for Use (IFU)
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Patients undergoing percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Van Mieghem, MD | Erasmus Medical Center Rotterdam Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Paul's Hospital | Vancouver | Canada | ||||
| Vancouver General Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25027520 | Background | Kadakia MB, Herrmann HC, Desai ND, Fox Z, Ogbara J, Anwaruddin S, Jagasia D, Bavaria JE, Szeto WY, Vallabhajosyula P, Li R, Menon R, Kobrin DM, Giri J. Factors associated with vascular complications in patients undergoing balloon-expandable transfemoral transcatheter aortic valve replacement via open versus percutaneous approaches. Circ Cardiovasc Interv. 2014 Aug;7(4):570-6. doi: 10.1161/CIRCINTERVENTIONS.113.001030. Epub 2014 Jul 15. | |
| 23026738 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Hemostasis | 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). | Time to Hemostasis (TTH) was captured in 491/500 subject; 9 subjects did not have TTH recorded. | Posted | Median | Inter-Quartile Range | seconds | Immediately after deployment of MANTA VCD |
|
|
Approximately 30 days after deployment of the MANTA device
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular access site haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darra Bigelow, Clinical Trials Manager | Essential Medical, a wholly owned subsidiary of Teleflex, Inc. | 610-331-7299 | darra.bigelow@teleflex.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2019 | Jul 21, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2020 | Jul 21, 2020 | SAP_001.pdf |
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| Vancouver |
| Canada |
| Aarhus University Hospital | Aarhus | Denmark |
| Helsinki University Hospital | Helsinki | Finland |
| University of Turku | Turku | Finland |
| OLVG | Amsterdam | Netherlands |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| Erasmus Medical Center | Rotterdam | Netherlands |
| Luzerner Kantonsspital | Lucerne | Switzerland |
| Background |
| Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants With One or More Major Access Site Related Complications | Major access site related complications adapted from the VARC-2 definitions | Posted | Count of Participants | Participants | within 30 days of procedure |
|
|
|
| Secondary | Number of Participants With One or More Minor Access Site Related Complications | Minor access site related complications adapted from the VARC-2 definitions | Posted | Count of Participants | Participants | within 30 days of procedure |
|
|
|
| 7 |
| 500 |
| 110 |
| 500 |
| 98 |
| 500 |
| Atrioventricular block | Cardiac disorders | Systematic Assessment |
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| Atrioventricular block first degree | Cardiac disorders | Systematic Assessment |
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| Bundle branch block left | Cardiac disorders | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | Systematic Assessment |
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| Paravalvular aortic regurgitation | Cardiac disorders | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea haemorrhagic | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | Systematic Assessment |
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| Retroperitoneal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Device embolisation | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Vascular access site infection | Infections and infestations | Systematic Assessment |
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| Viral infection | Infections and infestations | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular access site haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular access site bleeding-oozing | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular access site occlusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular procedure complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
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| Haemoglobin decreased | Investigations | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
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| Lead dislodgement | Product Issues | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cardiac pacemaker insertion | Surgical and medical procedures | Systematic Assessment |
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| Iliac artery perforation | Vascular disorders | Systematic Assessment |
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| Peripheral artery dissection | Vascular disorders | Systematic Assessment |
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| Peripheral artery stenosis | Vascular disorders | Systematic Assessment |
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| Peripheral artery thrombosis | Vascular disorders | Systematic Assessment |
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| Peripheral embolism | Vascular disorders | Systematic Assessment |
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| Vessel perforation | Vascular disorders | Systematic Assessment |
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| Vascular access site haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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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.