Recruiting

Observational Study

Sponsor:

Abbott Medical Devices

Code:

NCT04573660

Conditions

Acute Myocardial Infarction

Restenoses, Coronary

Coronary Artery Lesions

Venous Embolism

Arterial Embolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coronary and peripheral stents

Pacing catheters

Vascular plugs

Measurement and imaging (FFR and OCT)

Peripheral dilatation catheters

Study Details

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

Study ID

NCT04573660

Start date

Oct 25, 2020

Status verified date

Jul, 2025

Completion date

Nov, 2031

Anticipated

Primary completion date

Nov, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

3784 participants

Anticipated

Interventions and Outcome Measures

Arms

Coronary and peripheral stents

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

Vascular plugs

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)

Peripheral dilatation catheters

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

Coronary dilatation catheters

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

Coronary and peripheral guidewires

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

Vessel closure/compression devices

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

Vascular access introducers

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

Interventions

Coronary and peripheral stents

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

Pacing catheters

The participants in the Pacing catheters arm will receive Pacing catheters

Vascular plugs

The participants in the Vascular plugs arm will receive Vascular plugs

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

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

Coronary dilatation catheters

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

Coronary and peripheral guidewires

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

Vessel closure/compression devices

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

Vascular access introducers

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

Primary outcome measure

  • Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR) [ Time Frame: 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) [ Time Frame: 30 days ]
  • Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR) [ Time Frame: 12 months ]
  • Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR [ Time Frame: 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 [ Time Frame: 30 days ]
  • Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 days ]
  • Peripheral Stents (Renal Indication) - Number of participants with composite of TLR [ Time Frame: 12 months ]
  • Pacing Catheters - Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 30 days ]
  • Fractional flow reserve - Number of participants with composite of vessel dissection, perforation, and thromboembolism [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Sharan Dhanjal, MPH

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

Chinedu Agbonghai, MS

chinedu.agbonghai@abbott.com

Locations

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

Recruiting

Birmingham, Alabama, United States, 35249

Principal Investigator:

Dr. Mustafa Ahmed

Arkansas Heart Hospital

Recruiting

Little Rock, Arkansas, United States, 72211

Principal Investigator:

Vijay Raja, M.D.

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Principal Investigator:

Somjot Brar, MD

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

James D Flaherty, MD

Bryan Heart

Recruiting

Lincoln, Nebraska, United States, 68506

Principal Investigator:

Brock Cookman, M.D.

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Richard Gumina, M.D.

Wellmont CVA Heart Institute

Recruiting

Kingsport, Tennessee, United States, 37660

Principal Investigator:

Gaurav Rana, MD

More Information

Sponsor

Abbott Medical Devices

Last update posted

Jul 3, 2025

Last verified

Jul, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2025-07-03.