RECRUITING

Abbott Vascular Medical Device Registry

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Conditions

Acute Myocardial InfarctionRestenoses, CoronaryCoronary Artery LesionsVenous EmbolismArterial EmbolismCoronary and peripheral stentsABT-CIP-10349Vascular plugsPacing cathetersMeasurement and imaging (FFR and OCT)Peripheral dilatation cathetersCoronary dilatation cathetersCoronary and peripheral guidewiresVessel closure/compression devicesVascular access introducers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

Official Title

Abbott Vascular Medical Device Registry

Quick Facts

Study Start:2020-10-25
Study Completion:2031-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04573660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject is at least 18 years of age.
  2. 2. Subject has a planned procedure, or underwent a procedure, that will use/used one or more Abbott target devices covered in this registry.
  3. 3. Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol.
  4. 4. Subject must provide written informed consent prior to any clinical investigation-related data collection or be enrolled under an IRB/EC approved waiver of consent.
  1. 1. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months of the date of procedure.

Contacts and Locations

Study Contact

Sharan Dhanjal
CONTACT
+1 714-926-8292
sharanjeet.dhanjal@abbott.com
Elizabeth Peitzman, PhD
CONTACT
+1 651-249-8813
elizabeth.peitzman@abbott.com

Principal Investigator

Chananit Hutson, PhD
STUDY_DIRECTOR
Abbott Medical Devices

Study Locations (Sites)

University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35249
United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Bryan Heart
Lincoln, Nebraska, 68506
United States
Ohio State University
Columbus, Ohio, 43210
United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

  • Chananit Hutson, PhD, STUDY_DIRECTOR, Abbott Medical Devices

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-25
Study Completion Date2031-11

Study Record Updates

Study Start Date2020-10-25
Study Completion Date2031-11

Terms related to this study

Keywords Provided by Researchers

  • Coronary and peripheral stents
  • ABT-CIP-10349
  • Vascular plugs
  • Pacing catheters
  • Measurement and imaging (FFR and OCT)
  • Peripheral dilatation catheters
  • Coronary dilatation catheters
  • Coronary and peripheral guidewires
  • Vessel closure/compression devices
  • Vascular access introducers

Additional Relevant MeSH Terms

  • Acute Myocardial Infarction
  • Restenoses, Coronary
  • Coronary Artery Lesions
  • Venous Embolism
  • Arterial Embolism