Abbott Vascular Medical Device Registry

Summary

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.

Conditions

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

Interventions

DEVICE

Peripheral dilatation catheters

The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters

DEVICE

Coronary dilatation catheters

The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters

DEVICE

Coronary and peripheral guidewires

The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires

DEVICE

Vessel closure/compression devices

The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices

DEVICE

Vascular access introducers

The participants in the Vascular access introducers arm will receive Vascular access introducers

DEVICE

Coronary and peripheral stents

The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents

DEVICE

Pacing catheters

The participants in the Pacing catheters arm will receive Pacing catheters

DEVICE

Vascular plugs

The participants in the Vascular plugs arm will receive Vascular plugs

DEVICE

Measurement and imaging (FFR and OCT)

The participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)

Sponsors & Collaborators

• Abbott Medical Devices

  lead INDUSTRY

Principal Investigators

• Chananit Hutson, PhD · Abbott Medical Devices

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-25

Primary Completion

2030-11-30

Completion

2031-11-30

Countries

• United States
• Australia
• Austria
• Belgium
• China
• France
• Germany
• Hungary
• Italy
• Netherlands
• Spain
• Switzerland
• Taiwan
• United Arab Emirates

Study Locations