Abbott Vascular Medical Device Registry

Study Overview
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Brief Summary
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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.

Official Title
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Abbott Vascular Medical Device Registry

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

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary and peripheral stents<br>Participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents | Device: Coronary and peripheral stents<br>* The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents<br>|
| Pacing catheters<br>Participants in the Pacing catheters arm will receive Pacing catheters | Device: Pacing catheters<br>* The participants in the Pacing catheters arm will receive Pacing catheters<br>|
| Vascular plugs<br>Participants in the Vascular plugs arm will receive Vascular plugs | Device: Vascular plugs<br>* The participants in the Vascular plugs arm will receive Vascular plugs<br>|
| Measurement and imaging (FFR and OCT)<br>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)<br>* The participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)<br>|
| Peripheral dilatation catheters<br>Participants in the Peripheral dilatation catheters arm will receive Peripheral dilatation catheters | Device: Peripheral dilatation catheters<br>* The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters<br>|
| Coronary dilatation catheters<br>Participants in the Coronary dilatation catheters arm will receive Coronary dilatation catheters | Device: Coronary dilatation catheters<br>* The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters<br>|
| Coronary and peripheral guidewires<br>Participants in the Coronary and peripheral guidewires arm will receive Coronary and peripheral guidewires | Device: Coronary and peripheral guidewires<br>* The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires<br>|
| Vessel closure/compression devices<br>Participants in the Vessel closure/compression devices arm will receive Vessel closure/compression devices | Device: Vessel closure/compression devices<br>* The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices<br>|
| Vascular access introducers<br>Participants in the Vascular access introducers devices arm will receive Vascular access introducers | Device: Vascular access introducers<br>* The participants in the Vascular access introducers arm will receive Vascular access introducers<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Measurement and imaging (FFR and OCT), Peripheral dilatation catheters, Coronary dilatation catheters, Coronary and peripheral guidewires, Vessel closure/compression devices, Vascular access introducers, ABT-CIP-10349, Vascular plugs, Coronary and peripheral stents, Pacing catheters