Abbott Vascular Medical Device Registry (AV-MDR)

Abbott

Status: Enrolling

Conditions: Restenoses, Coronary; Venous Embolism; Coronary Artery Lesions; Arterial Embolism; Acute Myocardial Infarction

Treatments: Device: Coronary dilatation catheters; Device: Measurement and imaging (FFR and OCT); Device: Vessel closure/compression devices; Device: Pacing catheters; Device: Vascular access introducers; Device: Vascular plugs; Device: Coronary and peripheral stents; Device: Coronary and peripheral guidewires; Device: Peripheral dilatation catheters

Study type: Observational

Funder types: Industry

Identifiers

NCT04573660

ABT-CIP-10349

Details and patient eligibility

About

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.

Enrollment: 3,784 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is at least 18 years of age.
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. Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol.
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.

Exclusion criteria

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.

Trial design

3,784 participants in 9 patient groups

Coronary and peripheral stents

Description:

Participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents

Treatment:

Device: Coronary and peripheral stents

Pacing catheters

Description:

Participants in the Pacing catheters arm will receive Pacing catheters

Treatment:

Device: Pacing catheters

Vascular plugs

Description:

Participants in the Vascular plugs arm will receive Vascular plugs

Treatment:

Device: Vascular plugs

Measurement and imaging (FFR and OCT)

Description:

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

Treatment:

Device: Measurement and imaging (FFR and OCT)

Peripheral dilatation catheters

Description:

Participants in the Peripheral dilatation catheters arm will receive Peripheral dilatation catheters

Treatment:

Device: Peripheral dilatation catheters

Coronary dilatation catheters

Description:

Participants in the Coronary dilatation catheters arm will receive Coronary dilatation catheters

Treatment:

Device: Coronary dilatation catheters

Coronary and peripheral guidewires

Description:

Participants in the Coronary and peripheral guidewires arm will receive Coronary and peripheral guidewires

Treatment:

Device: Coronary and peripheral guidewires

Vessel closure/compression devices

Description:

Participants in the Vessel closure/compression devices arm will receive Vessel closure/compression devices

Treatment:

Device: Vessel closure/compression devices

Vascular access introducers

Description:

Participants in the Vascular access introducers devices arm will receive Vascular access introducers

Treatment:

Device: Vascular access introducers