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MANTA Registry for Vascular Large-bore Closure (MARVEL)

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: NCT03330002
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Essential Medical, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Femoral Arteriotomy Closure Device: CE-marked MANTA vascular closure device (VCD)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Post-Market Clinical Registry to Evaluate the Safety and Performance of MANTA Vascular Closure Device (VCD) Under Real World Conditions in the European Union (EU)
Actual Study Start Date : February 23, 2018
Actual Primary Completion Date : August 8, 2019
Estimated Study Completion Date : September 2020

Group/Cohort Intervention/treatment
CE-marked MANTA vascular closure devices per IFU
Transcatheter Aortic Valve Replacement (TAVR), Endovascular aneurysm repair (EVAR), TEVAR, etc.
Device: CE-marked MANTA vascular closure device (VCD)
Compile real word data on MANTA VCD.




Primary Outcome Measures :
  1. Time to Hemostasis [ Time Frame: Immediately after deployment of MANTA VCD ]
  2. Major femoral vascular complications [ Time Frame: within 30 days of procedure ]

Secondary Outcome Measures :
  1. Minor femoral vascular complications [ Time Frame: within 30 days of procedure ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.
Criteria
Per MANTA VCD Instructions for Use (IFU)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330002


Locations
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Canada
St Paul's Hospital
Vancouver, Canada
Vancouver General Health
Vancouver, Canada
Denmark
Aarhus University Hospital
Aarhus, Denmark
Finland
Helsinki University Hospital
Helsinki, Finland
University of Turku
Turku, Finland
Netherlands
OLVG
Amsterdam, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Switzerland
Luzerner Kantonsspital
Luzern, Switzerland
Sponsors and Collaborators
Essential Medical, Inc.
Investigators
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Principal Investigator: Nicolas Van Mieghem, MD Erasmus Medical Center Rotterdam Netherlands
Additional Information:

Publications:
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Responsible Party: Essential Medical, Inc.
ClinicalTrials.gov Identifier: NCT03330002    
Other Study ID Numbers: PSD-212
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not yet decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Essential Medical, Inc.:
Arterial Closure Device
Large Bore Closure Device