NCT04573660

Abbott Vascular Medical Device Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,784 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)
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

Timeline

• Start date: 2020-10-25
• Primary completion: 2030-11-01
• Completion: 2031-11-01
• First posted: 2020-10-05
• Last updated: 2025-07-03

Locations

37 sites across 14 countries: United States, Australia, Austria, Belgium, China, France, Germany, Hungary, Italy, Netherlands, Spain, Switzerland, Taiwan, United Arab Emirates