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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.

Tracking Information
First Submitted Date October 31, 2017
First Posted Date November 6, 2017
Last Update Posted Date July 7, 2020
Actual Study Start Date February 23, 2018
Actual Primary Completion Date August 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2017)
  • Time to Hemostasis [ Time Frame: Immediately after deployment of MANTA VCD ]
  • Major femoral vascular complications [ Time Frame: within 30 days of procedure ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 31, 2017)
Minor femoral vascular complications [ Time Frame: within 30 days of procedure ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MANTA Registry for Vascular Large-bore Closure
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)
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.
Condition Femoral Arteriotomy Closure
Intervention Device: CE-marked MANTA vascular closure device (VCD)
Compile real word data on MANTA VCD.
Study Groups/Cohorts CE-marked MANTA vascular closure devices per IFU
Transcatheter Aortic Valve Replacement (TAVR), Endovascular aneurysm repair (EVAR), TEVAR, etc.
Intervention: Device: CE-marked MANTA vascular closure device (VCD)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 31, 2017)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Actual Primary Completion Date August 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria Per MANTA VCD Instructions for Use (IFU)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Denmark,   Finland,   Netherlands,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03330002
Other Study ID Numbers PSD-212
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Not yet decided
Responsible Party Essential Medical, Inc.
Study Sponsor Essential Medical, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Nicolas Van Mieghem, MD Erasmus Medical Center Rotterdam Netherlands
PRS Account Essential Medical, Inc.
Verification Date July 2020