Abbott Vascular Medical Device Registry (AV-MDR)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myocardial Infarction; Restenoses, Coronary; Coronary Artery Lesions; Venous Embolism; Arterial Embolism
• Intervention / Treatment: Device: Coronary and peripheral stents; Device: Pacing catheters; Device: Vascular plugs; Device: Measurement and imaging (FFR and OCT); Device: Peripheral dilatation catheters; Device: Coronary dilatation catheters; Device: Coronary and peripheral guidewires; Device: Vessel closure/compression devices; Device: Vascular access introducers

• Study Type: Observational
• Enrollment (Estimated): 3784

Contacts and Locations

• Study Contact: Name: Sharan Dhanjal, MPH; Phone Number: +1 714-926-8292; Email: sharanjeet.dhanjal@abbott.com
• Study Contact Backup: Name: Chinedu Agbonghai, MS; Email: chinedu.agbonghai@abbott.com

Study Locations

• Australia
  • WAUS
    • Nedlands, WAUS, Australia, 6009
      • Recruiting
      • Perth Institute of Vascular Research
      • Principal Investigator: Bibombe Patrice Mwipatayi
    • Nedlands, WAUS, Australia, 6009
      • Recruiting
      • Sir Charles Gairdner Hospital
      • Principal Investigator: Carolina Bravo Ceballos
• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Universitätsklinik Graz
      • Principal Investigator: Hannes Deutschmann
• Belgium
  • Eflndrs
    • Aalst, Eflndrs, Belgium, 9300
      • Recruiting
      • Onze-Lieve-Vrouwziekenhuis Campus Aalst
      • Principal Investigator: Lieven Maene
    • Dendermonde, Eflndrs, Belgium, 9200
      • Recruiting
      • AZ Sint-Blasius Ziekenhuis
      • Principal Investigator: Koen Deloose
• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Principal Investigator: Jianfeng Han
  • Zhejian
    • Jinhua, Zhejian, China, 321000
      • Recruiting
      • Jinhua Municipal Central Hospital
      • Principal Investigator: Fengfeng Jiang, M.D.
    • Ningbo, Zhejian, China, 315000
      • Recruiting
      • Ningbo First Hospital
      • Principal Investigator: Zhiqing Lin
• France
  • Centre
    • Chartres, Centre, France, 28018
      • Recruiting
      • CH Chartres
      • Principal Investigator: Radwane Hakim
  • Ile
    • Paris, Ile, France, 75014
      • Completed
      • Hôpital Paris Saint-Joseph
• Germany
  • Hesse
    • Frankfurt, Hesse, Germany, 60389
      • Recruiting
      • Cardioangiologisches Centrum am Bethanien Krankenhaus
      • Principal Investigator: Michael Piorkowski
  • Rhinela
    • Mainz, Rhinela, Germany, 55131
      • Recruiting
      • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Principal Investigator: Prof. Dr. med. Christine Espinola-Klein
  • Saxon
    • Bad Bevensen, Saxon, Germany, 29549
      • Recruiting
      • Herz- u. Gefäßzentrum Bad Bevensen
      • Principal Investigator: Wulf Euringer
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Recruiting
      • Universitätsklinikum Leipzig AöR
      • Principal Investigator: Prof. Dr. med. Dierk Scheinert
  • Schlesw
    • Kiel, Schlesw, Germany, 24105
      • Recruiting
      • Universitätsklinikum Schleswig-Holstein Campus Kiel
      • Principal Investigator: Dr. Matthias Lutz
• Hungary
  • Budapest, Hungary, 1122
    • Recruiting
    • Semmelweis University
    • Principal Investigator: Béla Merkely
• Italy
  • Lombard
    • Milano, Lombard, Italy, 20138
      • Recruiting
      • Centro Cardiologico Monzino
      • Principal Investigator: Doctor Galli
    • Milano, Lombard, Italy, 20132
      • Completed
      • Ospedale San Raffaele
    • San Donato Milanese, Lombard, Italy, 20097
      • Recruiting
      • Policlinico San Donato
      • Contact: Francesco Bedogni, MD
• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • Completed
      • St. Antonius Ziekenhuis
• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario de La Paz
    • Principal Investigator: Raul Moreno
  • Catalon
    • Barcelona, Catalon, Spain, 08035
      • Recruiting
      • Hospital Universitari Vall d'Hebron
      • Principal Investigator: Sergi Bellmunt
  • Valncia
    • Alicante, Valncia, Spain, 03010
      • Recruiting
      • Hospital General Universitario de Alicante
      • Principal Investigator: Javier Irurzun
• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital - University Hospital of Bern
    • Principal Investigator: Marc Schindewolf, M.D.
  • Basel
    • Aarau, Basel, Switzerland, 5001
      • Recruiting
      • Kantonsspital Aarau
      • Principal Investigator: Hans Martin Gissler
• Taiwan
  • Mtaiwan
    • Taichung, Mtaiwan, Taiwan, 40705
      • Recruiting
      • Taichung Veterans General Hospital
      • Principal Investigator: Wen Lieng Lee
  • Ntaiwan
    • Taipei City, Ntaiwan, Taiwan, 106
      • Recruiting
      • Cathay General Hospital
      • Principal Investigator: Chi-Hung Huang
  • Staiwan
    • Tainan City, Staiwan, Taiwan, 704
      • Recruiting
      • National Cheng Kung University Hospital
      • Principal Investigator: Ju-Yi Chen
    • Tainan City, Staiwan, Taiwan, 710
      • Recruiting
      • Chi Mei Hospital
      • Principal Investigator: Zhih-Cherng Chen
• United Arab Emirates
  • Sharjah, United Arab Emirates, 3500
    • Recruiting
    • Al Qassimi Hospital
    • Principal Investigator: Arif Al Nooryani
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Recruiting
      • University Hospital - Univ. of Alabama at Birmingham (UAB)
      • Principal Investigator: Dr. Mustafa Ahmed
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Recruiting
      • Arkansas Heart Hospital
      • Principal Investigator: Vijay Raja, M.D.
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Kaiser Permanente Los Angeles Medical Center
      • Principal Investigator: Somjot Brar, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital
      • Principal Investigator: James D Flaherty, MD
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Recruiting
      • Bryan Heart
      • Principal Investigator: Brock Cookman, M.D.
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Principal Investigator: Richard Gumina, M.D.
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Recruiting
      • Wellmont CVA Heart Institute
      • Principal Investigator: Gaurav Rana, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will enroll subjects 18 years and older of all genders in which at least one Abbott target device specified in the CIP is used. Outcomes will be collected on any ancillary devices in scope, but patients will not be enrolled for use of an ancillary device without treatment with any target device. Patients must meet all general eligibility criteria and provide written informed consent or be enrolled under an IRB/EC approved waiver of consent, prior to sites' collection of patient data for the investigation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary and peripheral stents; Participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents	Device: Coronary and peripheral stents; The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
Pacing catheters; Participants in the Pacing catheters arm will receive Pacing catheters	Device: Pacing catheters; The participants in the Pacing catheters arm will receive Pacing catheters
Vascular plugs; Participants in the Vascular plugs arm will receive Vascular plugs	Device: Vascular plugs; The participants in the Vascular plugs arm will receive Vascular plugs
Measurement and imaging (FFR and OCT); Participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)	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)
Peripheral dilatation catheters; Participants in the Peripheral dilatation catheters arm will receive Peripheral dilatation catheters	Device: Peripheral dilatation catheters; The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters
Coronary dilatation catheters; Participants in the Coronary dilatation catheters arm will receive Coronary dilatation catheters	Device: Coronary dilatation catheters; The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters
Coronary and peripheral guidewires; Participants in the Coronary and peripheral guidewires arm will receive Coronary and peripheral guidewires	Device: Coronary and peripheral guidewires; The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires
Vessel closure/compression devices; Participants in the Vessel closure/compression devices arm will receive Vessel closure/compression devices	Device: Vessel closure/compression devices; The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices
Vascular access introducers; Participants in the Vascular access introducers devices arm will receive Vascular access introducers	Device: Vascular access introducers; The participants in the Vascular access introducers arm will receive Vascular access introducers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)	Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.	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)
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)	Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.	30 days
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)	Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.	12 months
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR	Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.	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)
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR	Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.	30 days
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR	Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.	12 months
Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR	Composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).	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)
Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR	Composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).	30 days
Peripheral Stents (Renal Indication) - Number of participants with composite of TLR	Composite of TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).	12 months
Pacing Catheters - Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)	Composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) will be assessed among the patients who receive Pacing Catheters.	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)
Pacing Catheters - Loss of capture (assessed based on physiological parameter-ECG)	Loss of capture (average time of loss of capture across patients) will be assessed among the patients who receive Pacing Catheters. ECG is used to measure whether the pacing device stimulates the heart. Absence of a stimulation is considered a loss of capture.	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)
Vascular Plugs - Number of participants with composite of potential complications (Implant success, occlusion success, migration)	Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive Vascular Plugs.	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)
Vascular Plugs - Number of participants with composite of occlusion success and migration	Composite of occlusion success and migration will be assessed among the patients who receive Vascular Plugs.	30 days
Fractional flow reserve - Number of participants with composite of vessel dissection, perforation, and thromboembolism	Composite of vessel dissection, perforation, and thromboembolism during procedure will be assessed among the patients who receive Fractional flow reserve (FFR).	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)
Fractional flow reserve - Number of participants with signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03)	Signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03) will be assessed among the patients who receive FFR.	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)
Optical Coherence Tomography Products - Number of participants with Intraprocedural complications (number of dissections ≥type B, slow flow or no reflow, thrombus, abrupt closure, perforation)	Intraprocedural complications will be assessed among the patients who receive Optical Coherence Tomography (OCT).	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)
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality pre-PCI	Successful crossing and image quality pre- PCI will be assessed among the patients who receive OCT.	During procedure - Before the stent is implanted (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality post-PCI	Successful crossing and image quality post-PCI will be assessed among the patients who receive OCT.	During procedure - Between 10-30 minutes post-PCI (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Peripheral Dilatation Catheters - Number of participants with Composite of major adverse events	Composite of major adverse events (e.g., distal embolization, dissection, perforation, amputation primary to balloon usage, total occlusion, abrupt closure, renal failure primary to balloon usage will be assessed among the patients who receive Peripheral Dilatation Catheters.	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)
Peripheral Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)	Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) will be assessed among the patients who receive Peripheral Dilatation Catheters. Device success can be summarized as the successful treatment with the device.	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)
Coronary Guidewires - Number of participants with Composite of major adverse events	Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Coronary Guidewires.	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)
Coronary Guidewires - Number of participants with Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion) (assessed based on physiological parameters)	Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion will be assessed among the patients who receive Coronary Guidewires. Device success can be summarized as the successful treatment with the device.	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)
Peripheral Guidewires - Number of participants with Composite of major adverse events	Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Peripheral Guidewires.	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)
Peripheral Guidewires - Number of participants with Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion) (assessed based on physiological parameters)	Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion will be assessed among the patients who receive Peripheral Guidewires. Device success can be summarized as the successful treatment with the device.	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)
Coronary Dilatation Catheters - Number of participants with Composite of major adverse events	Composite of major adverse events (e.g., distal embolization, dissection, perforation, amputation primary to balloon usage, total occlusion, abrupt closure, renal failure primary to balloon usage will be assessed among the patients who receive Coronary Dilatation Catheters.	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)
Coronary Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)	Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) will be assessed among the patients who receive Coronary Dilatation Catheters. Device success can be summarized as the successful treatment with the device.	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)
Vessel Closure Devices - Number of participants with Composite of access complications	Composite of access complications (e.g., hematoma, stenosis/occlusion, infection, access site bleeding) will be assessed among the patients who receive Vessel Closure Devices.	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)
Vessel Closure Devices - Number of participants with Successful hemostasis Major and minor bleeding	Successful hemostasis Major and minor bleeding will be assessed among the patients who receive Vessel Closure Devices.	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)
Vessel Compression Devices - Number of participants with Major and minor bleeding	Major and minor bleeding will be assessed among the patients who receive Vessel Compression Devices.	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)
Vessel Compression Devices - Number of participants with Complications including: pseudoaneurysm, hematoma (>5cm) in diameter, Hb drop>20 g/L, extended compression time >6 hours, blood transfusion required, bleeding requiring surgical procedure	Complications including: pseudoaneurysm requiring treatment, hematoma (>5cm) in diameter, Hb drop>20 g/L, extended compression time >6 hours, blood transfusion required, bleeding requiring surgical procedure will be assessed among the patients who receive Vessel Compression Devices.	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)
Vascular Access Introducers - Incidence of safety issues	Incidence of safety issues (e.g., bleeding, air embolism, hematoma, vessel damage (dissection, perforation, pseudoaneurysm), infection, thrombosis, AV fistula, occlusion, radial artery spasm) will be assessed among the patients who receive Vascular Access Introducers.	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)
Vascular Access Introducers - Incidence of performance issues	Incidence of performance issues (e.g., unable to introduce other devices, failure to maintain hemostasis valve integrity, air leakage, bending or kinking of introducer, difficulty inserting/removing the sheath, device breakage detachment or separation, issue with an associated accessory) will be assessed among the patients who receive Vascular Access Introducers.	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)

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Chananit Hutson, PhD, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2020
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2031

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: 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: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Embolism and Thrombosis; Coronary Disease; Myocardial Ischemia; Ischemia; Coronary Stenosis; Embolism; Myocardial Infarction; Infarction; Coronary Restenosis
• Other Study ID Numbers: ABT-CIP-10349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No