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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
Scientific title
Abbott Vascular Medical Device Registry
Secondary ID [1] 0 0
ABT-CIP-10349
Universal Trial Number (UTN)
Trial acronym
AV-MDR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 0 0
Restenoses, Coronary 0 0
Coronary Artery Lesions 0 0
Venous Embolism 0 0
Arterial Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
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)
Primary outcome [2] 0 0
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
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)
Primary outcome [5] 0 0
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Timepoint [5] 0 0
30 days
Primary outcome [6] 0 0
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Timepoint [6] 0 0
12 months
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
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)
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
Timepoint [8] 0 0
30 days
Primary outcome [9] 0 0
Peripheral Stents (Renal Indication) - Number of participants with composite of TLR
Timepoint [9] 0 0
12 months
Primary outcome [10] 0 0
Pacing Catheters - Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)
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)
Primary outcome [11] 0 0
Pacing Catheters - Loss of capture (assessed based on physiological parameter-ECG)
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)
Primary outcome [12] 0 0
Vascular Plugs - Number of participants with composite of potential complications (Implant success, occlusion success, migration)
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)
Primary outcome [13] 0 0
Vascular Plugs - Number of participants with composite of occlusion success and migration
Timepoint [13] 0 0
30 days
Primary outcome [14] 0 0
Fractional flow reserve - Number of participants with composite of vessel dissection, perforation, and thromboembolism
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)
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)
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)
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)
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)
Primary outcome [17] 0 0
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality pre-PCI
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)
Primary outcome [18] 0 0
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality post-PCI
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)
Primary outcome [19] 0 0
Peripheral Dilatation Catheters - Number of participants with Composite of major adverse events
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)
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)
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)
Primary outcome [21] 0 0
Coronary Guidewires - Number of participants with Composite of major adverse events
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)
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)
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)
Primary outcome [23] 0 0
Peripheral Guidewires - Number of participants with Composite of major adverse events
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)
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)
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)
Primary outcome [25] 0 0
Coronary Dilatation Catheters - Number of participants with Composite of major adverse events
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)
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)
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)
Primary outcome [27] 0 0
Vessel Closure Devices - Number of participants with Composite of access complications
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)
Primary outcome [28] 0 0
Vessel Closure Devices - Number of participants with Successful hemostasis Major and minor bleeding
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)
Primary outcome [29] 0 0
Vessel Compression Devices - Number of participants with Major and minor bleeding
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)
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
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)
Primary outcome [31] 0 0
Vascular Access Introducers - Incidence of safety issues
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)
Primary outcome [32] 0 0
Vascular Access Introducers - Incidence of performance issues
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)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2031
Actual
Sample size
Target
3784
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WAU
Recruitment hospital [1] 0 0
Perth Institute of Vascular Research - Nedlands
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
Austria
State/province [8] 0 0
Styria
Country [9] 0 0
Belgium
State/province [9] 0 0
Eflndrs
Country [10] 0 0
China
State/province [10] 0 0
Shaanxi
Country [11] 0 0
China
State/province [11] 0 0
Zhejian
Country [12] 0 0
France
State/province [12] 0 0
Centre
Country [13] 0 0
France
State/province [13] 0 0
Ile
Country [14] 0 0
Germany
State/province [14] 0 0
Hesse
Country [15] 0 0
Germany
State/province [15] 0 0
Rhinela
Country [16] 0 0
Germany
State/province [16] 0 0
Saxony
Country [17] 0 0
Germany
State/province [17] 0 0
Saxon
Country [18] 0 0
Germany
State/province [18] 0 0
Schlesw
Country [19] 0 0
Hungary
State/province [19] 0 0
Budapest
Country [20] 0 0
Italy
State/province [20] 0 0
Lombard
Country [21] 0 0
Netherlands
State/province [21] 0 0
Utrecht
Country [22] 0 0
Spain
State/province [22] 0 0
Catalon
Country [23] 0 0
Spain
State/province [23] 0 0
Valncia
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Switzerland
State/province [25] 0 0
Basel
Country [26] 0 0
Switzerland
State/province [26] 0 0
Bern
Country [27] 0 0
Taiwan
State/province [27] 0 0
Mtaiwan
Country [28] 0 0
Taiwan
State/province [28] 0 0
Ntaiwan
Country [29] 0 0
Taiwan
State/province [29] 0 0
Staiwan
Country [30] 0 0
United Arab Emirates
State/province [30] 0 0
Sharjah

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04573660
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chananit Hutson, PhD
Address 0 0
Abbott Medical Devices
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sharan Dhanjal
Address 0 0
Country 0 0
Phone 0 0
+1 714-926-8292
Fax 0 0
Email 0 0
sharanjeet.dhanjal@abbott.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04573660