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 Type
OBSERVATIONAL
Enrollment
3,784
The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
The participants in the Pacing catheters arm will receive Pacing catheters
The participants in the Vascular plugs arm will receive Vascular plugs
The participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)
The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters
The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters
The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires
The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices
The participants in the Vascular access introducers arm will receive Vascular access introducers
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
RECRUITINGArkansas Heart Hospital
Little Rock, Arkansas, United States
RECRUITINGKaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
RECRUITINGNorthwestern Memorial Hospital
Chicago, Illinois, United States
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.
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)
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Time frame: 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.
Time frame: 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.
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
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Time frame: 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.
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
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).
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
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).
Time frame: 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).
Time frame: 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.
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)
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.
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)
Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive Vascular Plugs.
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
Composite of occlusion success and migration will be assessed among the patients who receive Vascular Plugs.
Time frame: 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).
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)
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.
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)
Intraprocedural complications will be assessed among the patients who receive Optical Coherence Tomography (OCT).
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
Successful crossing and image quality pre- PCI will be assessed among the patients who receive OCT.
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
Successful crossing and image quality post-PCI will be assessed among the patients who receive OCT.
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
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.
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)
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.
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
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Coronary Guidewires.
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)
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.
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
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Peripheral Guidewires.
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)
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.
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
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.
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)
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.
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
Composite of access complications (e.g., hematoma, stenosis/occlusion, infection, access site bleeding) will be assessed among the patients who receive Vessel Closure Devices.
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
Successful hemostasis Major and minor bleeding will be assessed among the patients who receive Vessel Closure Devices.
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
Major and minor bleeding will be assessed among the patients who receive Vessel Compression Devices.
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
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.
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
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.
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
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.
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)
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Bryan Heart
Lincoln, Nebraska, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGWellmont CVA Heart Institute
Kingsport, Tennessee, United States
RECRUITINGPerth Institute of Vascular Research
Nedlands, WAUS, Australia
RECRUITINGSir Charles Gairdner Hospital
Nedlands, WAUS, Australia
RECRUITINGUniversitätsklinik Graz
Graz, Styria, Austria
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