NCT04573660 · Abbott Medical Devices
Abbott Vascular Medical Device Registry
(AV-MDR)
What this study is about
The AV-MDR is a forward-looking, non-randomly assigned, where both patients and doctors know the treatment given, multi-center registry.
View original scientific description
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.
Interventions
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
Primary outcome measures
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)
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Time frame: 30 days
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Time frame: 12 months
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
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)
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Time frame: 30 days
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Time frame: 12 months
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
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)
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).
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
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).
Peripheral Stents (Renal Indication) - Number of participants with composite of TLR
Time frame: 12 months
Composite of TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
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)
Composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) will be assessed among the patients who receive Pacing Catheters.
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)
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.
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)
Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive Vascular Plugs.
Vascular Plugs - Number of participants with composite of occlusion success and migration
Time frame: 30 days
Composite of occlusion success and migration will be assessed among the patients who receive Vascular Plugs.
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)
Composite of vessel dissection, perforation, and thromboembolism during procedure will be assessed among the patients who receive Fractional flow reserve (FFR).
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)
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.
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)
Intraprocedural complications will be assessed among the patients who receive Optical Coherence Tomography (OCT).
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)
Successful crossing and image quality pre- PCI will be assessed among the patients who receive OCT.
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)
Successful crossing and image quality post-PCI will be assessed among the patients who receive OCT.
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)
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.
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)
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.
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)
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Coronary Guidewires.
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)
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.
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)
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Peripheral Guidewires.
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)
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.
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)
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.
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)
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.
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)
Composite of access complications (e.g., hematoma, stenosis/occlusion, infection, access site bleeding) will be assessed among the patients who receive Vessel Closure Devices.
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)
Successful hemostasis Major and minor bleeding will be assessed among the patients who receive Vessel Closure Devices.
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)
Major and minor bleeding will be assessed among the patients who receive Vessel Compression Devices.
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)
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.
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)
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.
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)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
- Little Rock, Arkansas
- Los Angeles, California
- Chicago, Illinois
- Lincoln, Nebraska
- Columbus, Ohio
- Kingsport, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 3, 2025 · Source of record for eligibility and locations