Abbott Vascular Medical Device Registry

NCT04573660 | Recruiting

• 1 other identifier: ABT-CIP-10349
• Study Type: observational
• Target: 3,784
• Locations: 13 countries
• Sites: 36

Brief 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

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

Outcome Measures

Primary Outcomes (32)

• 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)

Study Arms (9)

Coronary and peripheral stents

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

Device: Coronary and peripheral stents

Pacing catheters

Participants in the Pacing catheters arm will receive Pacing catheters

Device: Pacing catheters

Vascular plugs

Participants in the Vascular plugs arm will receive Vascular plugs

Device: 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)

Peripheral dilatation catheters

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

Device: Peripheral dilatation catheters

Coronary dilatation catheters

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

Device: 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

Vessel closure/compression devices

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

Device: Vessel closure/compression devices

Vascular access introducers

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

Device: Vascular access introducers

Interventions

Coronary and peripheral stents DEVICE

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

Coronary and peripheral stents

Pacing catheters DEVICE

The participants in the Pacing catheters arm will receive Pacing catheters

Pacing catheters

Vascular plugs DEVICE

The participants in the Vascular plugs arm will receive Vascular plugs

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)

Measurement and imaging (FFR and OCT)

Peripheral dilatation catheters DEVICE

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

Peripheral dilatation catheters

Coronary dilatation catheters DEVICE

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

Coronary dilatation catheters

Coronary and peripheral guidewires DEVICE

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

Coronary and peripheral guidewires

Vessel closure/compression devices DEVICE

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

Vessel closure/compression devices

Vascular access introducers DEVICE

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

Vascular access introducers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject is at least 18 years of age.
• Subject has a planned procedure, or underwent a procedure, that will use/used one or more Abbott target devices covered in this registry.
• Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol.
• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (37)

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35249, United States

RECRUITING

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Bryan Heart

Lincoln, Nebraska, 68506, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

RECRUITING

Perth Institute of Vascular Research

Nedlands, WAUS, 6009, Australia

RECRUITING

Sir Charles Gairdner Hospital

Nedlands, WAUS, 6009, Australia

RECRUITING

Universitätsklinik Graz

Graz, Styria, 8036, Austria

RECRUITING

Onze-Lieve-Vrouwziekenhuis Campus Aalst

Aalst, Eflndrs, 9300, Belgium

RECRUITING

AZ Sint-Blasius Ziekenhuis

Dendermonde, Eflndrs, 9200, Belgium

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Jinhua Municipal Central Hospital

Jinhua, Zhejian, 321000, China

RECRUITING

Ningbo First Hospital

Ningbo, Zhejian, 315000, China

RECRUITING

CH Chartres

Chartres, Centre-Val de Loire, 28018, France

RECRUITING

Hôpital Paris Saint-Joseph

Paris, Ile, 75014, France

COMPLETED

Cardioangiologisches Centrum am Bethanien Krankenhaus

Frankfurt am Main, Hesse, 60389, Germany

RECRUITING

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhinela, 55131, Germany

RECRUITING

Universitätsklinikum Leipzig AÖR

Leipzig, Saxony, 04103, Germany

RECRUITING

Herz- u. Gefäßzentrum Bad Bevensen

Bad Bevensen, Saxon, 29549, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schlesw, 24105, Germany

RECRUITING

Semmelweis University

Budapest, Budapest, 1122, Hungary

RECRUITING

Ospedale San Raffaele

Milan, Lombard, 20132, Italy

COMPLETED

Centro Cardiologico Monzino

Milan, Lombard, 20138, Italy

RECRUITING

Policlinico San Donato

San Donato Milanese, Lombard, 20097, Italy

RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435 CM, Netherlands

COMPLETED

Hospital Universitari Vall d'Hebron

Barcelona, Catalon, 08035, Spain

RECRUITING

Hospital Universitario de la Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital General Universitario de Alicante

Alicante, Valncia, 03010, Spain

RECRUITING

Kantonsspital Aarau

Aarau, Basel, 5001, Switzerland

RECRUITING

Inselspital - University Hospital of Bern

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Taichung Veterans General Hospital

Taichung, Mtaiwan, 40705, Taiwan

RECRUITING

Cathay General Hospital

Taipei, Ntaiwan, 106, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Staiwan, 704, Taiwan

RECRUITING

Chi Mei Hospital

Tainan, Staiwan, 710, Taiwan

RECRUITING

Al Qassimi Hospital

Sharjah city, Emirate of Sharjah, 3500, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Coronary Restenosis; Ornithine Carbamoyltransferase Deficiency Disease

Interventions

Weights and Measures; Diagnostic Imaging; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography, Optical; Optical Imaging; Tomography

Study Officials

• Chananit Hutson, PhD

  Abbott Medical Devices

  STUDY DIRECTOR

Central Study Contacts

Sharan Dhanjal, MPH

CONTACT

+1 714-926-8292; sharanjeet.dhanjal@abbott.com

Chinedu Agbonghai, MS

CONTACT

chinedu.agbonghai@abbott.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 5, 2020
• Study Start: October 25, 2020
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2031
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); US (7); IT (3); ES (3); AE (1); HU (1); BE (2); DE (5); NL (1); CH (2); TW (4); FR (2); CN (3)