Abbott Vascular Medical Device Registry

Acute Myocardial Infarction Clinical Trial

— AV-MDR  

Official title:

Abbott Vascular Medical Device Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573660
• Other study ID #: ABT-CIP-10349
• Status: Recruiting
• Start date: October 25, 2020
• Est. completion date: November 2031

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: Sharan Dhanjal
• Phone: +1 714-926-8292
• Email: sharanjeet.dhanjal[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3784
• Est. completion date: November 2031
• Est. primary completion date: November 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Arterial Embolism
• Coronary Artery Lesions
• Coronary Restenosis
• Embolism
• Infarction
• Myocardial Infarction
• Restenoses, Coronary
• Venous Embolism

Intervention

Device:
• Coronary and peripheral stents
The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
• Pacing catheters
The participants in the Pacing catheters arm will receive Pacing catheters
• Vascular plugs
The participants in the Vascular plugs arm will receive Vascular plugs
• 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)
• Peripheral dilatation catheters
The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters
• Coronary dilatation catheters
The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters
• Coronary and peripheral guidewires
The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires
• Vessel closure/compression devices
The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices
• Vascular access introducers
The participants in the Vascular access introducers arm will receive Vascular access introducers

Locations

Country	Name	City	State
Australia	Perth Institute of Vascular Research	Nedlands	WAUS
Australia	Sir Charles Gairdner Hospital	Nedlands	WAUS
Austria	Universitätsklinik Graz	Graz	Styria
Belgium	Onze-Lieve-Vrouwziekenhuis Campus Aalst	Aalst	Eflndrs
Belgium	AZ Sint-Blasius Ziekenhuis	Dendermonde	Eflndrs
China	Jinhua Municipal Central Hospital	Jinhua	Zhejian
China	Ningbo First Hospital	Ningbo	Zhejian
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
France	CH Chartres	Chartres	Centre
France	Hôpital Paris Saint-Joseph	Paris	Ile
Germany	Herz- u. Gefäßzentrum Bad Bevensen	Bad Bevensen	Saxon
Germany	Cardioangiologisches Centrum am Bethanien Krankenhaus	Frankfurt	Hesse
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel	Schlesw
Germany	Universitätsklinikum Leipzig AÖR	Leipzig	Saxony
Germany	UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz	Mainz	Rhinela
Hungary	Semmelweis University	Budapest
Italy	Centro Cardiologico Monzino	Milano	Lombard
Italy	Ospedale San Raffaele	Milano	Lombard
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht
Spain	Hospital General Universitario de Alicante	Alicante	Valncia
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Catalon
Spain	Hospital Universitario de la Paz	Madrid
Switzerland	Kantonsspital Aarau	Aarau	Basel
Switzerland	Inselspital - University Hospital of Bern	Bern
Taiwan	Taichung Veterans General Hospital	Taichung	Mtaiwan
Taiwan	Chi Mei Hospital	Tainan City	Staiwan
Taiwan	National Cheng Kung University Hospital	Tainan City	Staiwan
Taiwan	Cathay General Hospital	Taipei City	Ntaiwan
United Arab Emirates	Al Qassimi Hospital	Sharjah
United States	University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	Bryan Heart	Lincoln	Nebraska
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  China,  France,  Germany,  Hungary,  Italy,  Netherlands,  Spain,  Switzerland,  Taiwan,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)