Abbott Vascular Medical Device Registry

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Abbott Medical Devices
Study ID
NCT04573660
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Coronary and peripheral stents — DEVICE
    The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
  • Pacing catheters — DEVICE
    The participants in the Pacing catheters arm will receive Pacing catheters
  • Vascular plugs — DEVICE
    The participants in the Vascular plugs arm will receive Vascular plugs
  • Measurement and imaging (FFR and OCT) — DEVICE
    The participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)
  • Peripheral dilatation catheters — DEVICE
    The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters
  • Coronary dilatation catheters — DEVICE
    The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters
  • Coronary and peripheral guidewires — DEVICE
    The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires
  • Vessel closure/compression devices — DEVICE
    The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices
  • Vascular access introducers — DEVICE
    The participants in the Vascular access introducers arm will receive Vascular access introducers

Study Details

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.

Key Dates

Start date
Oct 25, 2020
Status verified
Jul 2025
Primary completion
Nov 30, 2030
Completion
Nov 30, 2031

Study Design

Enrollment
3,784 participants (estimated)

Arms

  • Arm: Coronary and peripheral stents
    Participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
  • Arm: Pacing catheters
    Participants in the Pacing catheters arm will receive Pacing catheters
  • Arm: Vascular plugs
    Participants in the Vascular plugs arm will receive Vascular plugs
  • Arm: Measurement and imaging (FFR and OCT)
    Participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)
  • Arm: Peripheral dilatation catheters
    Participants in the Peripheral dilatation catheters arm will receive Peripheral dilatation catheters
  • Arm: Coronary dilatation catheters
    Participants in the Coronary dilatation catheters arm will receive Coronary dilatation catheters
  • Arm: Coronary and peripheral guidewires
    Participants in the Coronary and peripheral guidewires arm will receive Coronary and peripheral guidewires
  • Arm: Vessel closure/compression devices
    Participants in the Vessel closure/compression devices arm will receive Vessel closure/compression devices
  • Arm: Vascular access introducers
    Participants in the Vascular access introducers devices arm will receive Vascular access introducers

Primary Outcome Measure

Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR) [ Time Frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University Hospital - Univ. of Alabama at Birmingham (UAB)BirminghamAlabama35249
Dr. Mustafa Ahmed (PRINCIPAL_INVESTIGATOR)
Arkansas Heart HospitalLittle RockArkansas72211
Vijay Raja, M.D. (PRINCIPAL_INVESTIGATOR)
Kaiser Permanente Los Angeles Medical CenterLos AngelesCalifornia90027
Somjot Brar, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60611
James D Flaherty, MD (PRINCIPAL_INVESTIGATOR)
Bryan HeartLincolnNebraska68506
Brock Cookman, M.D. (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Richard Gumina, M.D. (PRINCIPAL_INVESTIGATOR)
Wellmont CVA Heart InstituteKingsportTennessee37660
Gaurav Rana, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University Hospital - Univ. of Alabama at Birmingham (UAB)· Birmingham, ALArkansas Heart Hospital· Little Rock, ARKaiser Permanente Los Angeles Medical Center· Los Angeles, CANorthwestern Memorial Hospital· Chicago, ILBryan Heart· Lincoln, NEOhio State University· Columbus, OH

Related Studies