Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04573660
Registration number
NCT04573660
Ethics application status
Date submitted
23/09/2020
Date registered
5/10/2020
Date last updated
29/05/2024
Titles & IDs
Public title
Abbott Vascular Medical Device Registry
Query!
Scientific title
Abbott Vascular Medical Device Registry
Query!
Secondary ID [1]
0
0
ABT-CIP-10349
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
AV-MDR
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction
0
0
Query!
Restenoses, Coronary
0
0
Query!
Coronary Artery Lesions
0
0
Query!
Venous Embolism
0
0
Query!
Arterial Embolism
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Treatment: Devices - Coronary and peripheral stents
Treatment: Devices - Pacing catheters
Treatment: Devices - Vascular plugs
Treatment: Devices - Measurement and imaging (FFR and OCT)
Treatment: Devices - Peripheral dilatation catheters
Treatment: Devices - Coronary dilatation catheters
Treatment: Devices - Coronary and peripheral guidewires
Treatment: Devices - Vessel closure/compression devices
Treatment: Devices - Vascular access introducers
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
Treatment: Devices: Coronary and peripheral stents
The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
Treatment: Devices: Pacing catheters
The participants in the Pacing catheters arm will receive Pacing catheters
Treatment: Devices: Vascular plugs
The participants in the Vascular plugs arm will receive Vascular plugs
Treatment: Devices: 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)
Treatment: Devices: Peripheral dilatation catheters
The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters
Treatment: Devices: Coronary dilatation catheters
The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters
Treatment: Devices: Coronary and peripheral guidewires
The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires
Treatment: Devices: Vessel closure/compression devices
The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices
Treatment: Devices: Vascular access introducers
The participants in the Vascular access introducers arm will receive Vascular access introducers
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Query!
Assessment method [1]
0
0
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Query!
Timepoint [1]
0
0
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)
Query!
Primary outcome [2]
0
0
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Query!
Assessment method [2]
0
0
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Query!
Timepoint [2]
0
0
30 days
Query!
Primary outcome [3]
0
0
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Query!
Assessment method [3]
0
0
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Query!
Timepoint [3]
0
0
12 months
Query!
Primary outcome [4]
0
0
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Query!
Assessment method [4]
0
0
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Query!
Timepoint [4]
0
0
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)
Query!
Primary outcome [5]
0
0
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Query!
Assessment method [5]
0
0
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Query!
Timepoint [5]
0
0
30 days
Query!
Primary outcome [6]
0
0
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Query!
Assessment method [6]
0
0
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Query!
Timepoint [6]
0
0
12 months
Query!
Primary outcome [7]
0
0
Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR
Query!
Assessment method [7]
0
0
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).
Query!
Timepoint [7]
0
0
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)
Query!
Primary outcome [8]
0
0
Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR
Query!
Assessment method [8]
0
0
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).
Query!
Timepoint [8]
0
0
30 days
Query!
Primary outcome [9]
0
0
Peripheral Stents (Renal Indication) - Number of participants with composite of TLR
Query!
Assessment method [9]
0
0
Composite of TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
Query!
Timepoint [9]
0
0
12 months
Query!
Primary outcome [10]
0
0
Pacing Catheters - Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)
Query!
Assessment method [10]
0
0
Composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) will be assessed among the patients who receive Pacing Catheters.
Query!
Timepoint [10]
0
0
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)
Query!
Primary outcome [11]
0
0
Pacing Catheters - Loss of capture (assessed based on physiological parameter-ECG)
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
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)
Query!
Primary outcome [12]
0
0
Vascular Plugs - Number of participants with composite of potential complications (Implant success, occlusion success, migration)
Query!
Assessment method [12]
0
0
Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive Vascular Plugs.
Query!
Timepoint [12]
0
0
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)
Query!
Primary outcome [13]
0
0
Vascular Plugs - Number of participants with composite of occlusion success and migration
Query!
Assessment method [13]
0
0
Composite of occlusion success and migration will be assessed among the patients who receive Vascular Plugs.
Query!
Timepoint [13]
0
0
30 days
Query!
Primary outcome [14]
0
0
Fractional flow reserve - Number of participants with composite of vessel dissection, perforation, and thromboembolism
Query!
Assessment method [14]
0
0
Composite of vessel dissection, perforation, and thromboembolism during procedure will be assessed among the patients who receive Fractional flow reserve (FFR).
Query!
Timepoint [14]
0
0
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)
Query!
Primary outcome [15]
0
0
Fractional flow reserve - Number of participants with signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03)
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
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)
Query!
Primary outcome [16]
0
0
Optical Coherence Tomography Products - Number of participants with Intraprocedural complications (number of dissections =type B, slow flow or no reflow, thrombus, abrupt closure, perforation)
Query!
Assessment method [16]
0
0
Intraprocedural complications will be assessed among the patients who receive Optical Coherence Tomography (OCT).
Query!
Timepoint [16]
0
0
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)
Query!
Primary outcome [17]
0
0
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality pre-PCI
Query!
Assessment method [17]
0
0
Successful crossing and image quality pre- PCI will be assessed among the patients who receive OCT.
Query!
Timepoint [17]
0
0
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)
Query!
Primary outcome [18]
0
0
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality post-PCI
Query!
Assessment method [18]
0
0
Successful crossing and image quality post-PCI will be assessed among the patients who receive OCT.
Query!
Timepoint [18]
0
0
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)
Query!
Primary outcome [19]
0
0
Peripheral Dilatation Catheters - Number of participants with Composite of major adverse events
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
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)
Query!
Primary outcome [20]
0
0
Peripheral Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)
Query!
Assessment method [20]
0
0
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.
Query!
Timepoint [20]
0
0
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)
Query!
Primary outcome [21]
0
0
Coronary Guidewires - Number of participants with Composite of major adverse events
Query!
Assessment method [21]
0
0
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Coronary Guidewires.
Query!
Timepoint [21]
0
0
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)
Query!
Primary outcome [22]
0
0
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)
Query!
Assessment method [22]
0
0
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.
Query!
Timepoint [22]
0
0
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)
Query!
Primary outcome [23]
0
0
Peripheral Guidewires - Number of participants with Composite of major adverse events
Query!
Assessment method [23]
0
0
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Peripheral Guidewires.
Query!
Timepoint [23]
0
0
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)
Query!
Primary outcome [24]
0
0
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)
Query!
Assessment method [24]
0
0
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.
Query!
Timepoint [24]
0
0
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)
Query!
Primary outcome [25]
0
0
Coronary Dilatation Catheters - Number of participants with Composite of major adverse events
Query!
Assessment method [25]
0
0
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.
Query!
Timepoint [25]
0
0
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)
Query!
Primary outcome [26]
0
0
Coronary Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)
Query!
Assessment method [26]
0
0
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.
Query!
Timepoint [26]
0
0
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)
Query!
Primary outcome [27]
0
0
Vessel Closure Devices - Number of participants with Composite of access complications
Query!
Assessment method [27]
0
0
Composite of access complications (e.g., hematoma, stenosis/occlusion, infection, access site bleeding) will be assessed among the patients who receive Vessel Closure Devices.
Query!
Timepoint [27]
0
0
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)
Query!
Primary outcome [28]
0
0
Vessel Closure Devices - Number of participants with Successful hemostasis Major and minor bleeding
Query!
Assessment method [28]
0
0
Successful hemostasis Major and minor bleeding will be assessed among the patients who receive Vessel Closure Devices.
Query!
Timepoint [28]
0
0
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)
Query!
Primary outcome [29]
0
0
Vessel Compression Devices - Number of participants with Major and minor bleeding
Query!
Assessment method [29]
0
0
Major and minor bleeding will be assessed among the patients who receive Vessel Compression Devices.
Query!
Timepoint [29]
0
0
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)
Query!
Primary outcome [30]
0
0
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
Query!
Assessment method [30]
0
0
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.
Query!
Timepoint [30]
0
0
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)
Query!
Primary outcome [31]
0
0
Vascular Access Introducers - Incidence of safety issues
Query!
Assessment method [31]
0
0
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.
Query!
Timepoint [31]
0
0
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)
Query!
Primary outcome [32]
0
0
Vascular Access Introducers - Incidence of performance issues
Query!
Assessment method [32]
0
0
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.
Query!
Timepoint [32]
0
0
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)
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/10/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/11/2031
Query!
Actual
Query!
Sample size
Target
3784
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
WAU
Query!
Recruitment hospital [1]
0
0
Perth Institute of Vascular Research - Nedlands
Query!
Recruitment hospital [2]
0
0
Sir Charles Gairdner Hospital - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Nebraska
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Ohio
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Tennessee
Query!
Country [8]
0
0
Austria
Query!
State/province [8]
0
0
Styria
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Eflndrs
Query!
Country [10]
0
0
China
Query!
State/province [10]
0
0
Shaanxi
Query!
Country [11]
0
0
China
Query!
State/province [11]
0
0
Zhejian
Query!
Country [12]
0
0
France
Query!
State/province [12]
0
0
Centre
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Ile
Query!
Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Hesse
Query!
Country [15]
0
0
Germany
Query!
State/province [15]
0
0
Rhinela
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
Saxony
Query!
Country [17]
0
0
Germany
Query!
State/province [17]
0
0
Saxon
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Schlesw
Query!
Country [19]
0
0
Hungary
Query!
State/province [19]
0
0
Budapest
Query!
Country [20]
0
0
Italy
Query!
State/province [20]
0
0
Lombard
Query!
Country [21]
0
0
Netherlands
Query!
State/province [21]
0
0
Utrecht
Query!
Country [22]
0
0
Spain
Query!
State/province [22]
0
0
Catalon
Query!
Country [23]
0
0
Spain
Query!
State/province [23]
0
0
Valncia
Query!
Country [24]
0
0
Spain
Query!
State/province [24]
0
0
Madrid
Query!
Country [25]
0
0
Switzerland
Query!
State/province [25]
0
0
Basel
Query!
Country [26]
0
0
Switzerland
Query!
State/province [26]
0
0
Bern
Query!
Country [27]
0
0
Taiwan
Query!
State/province [27]
0
0
Mtaiwan
Query!
Country [28]
0
0
Taiwan
Query!
State/province [28]
0
0
Ntaiwan
Query!
Country [29]
0
0
Taiwan
Query!
State/province [29]
0
0
Staiwan
Query!
Country [30]
0
0
United Arab Emirates
Query!
State/province [30]
0
0
Sharjah
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Abbott Medical Devices
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04573660
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Chananit Hutson, PhD
Query!
Address
0
0
Abbott Medical Devices
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Sharan Dhanjal
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+1 714-926-8292
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04573660
Download to PDF