Clinical trial NCT04573660: Abbott Vascular Medical Device Registry
Official title: Abbott Vascular Medical Device Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myocardial Infarction
Restenoses, Coronary
Coronary Artery Lesions
Venous Embolism
Arterial Embolism
Keywords: Coronary and peripheral stents
ABT-CIP-10349
Vascular plugs
Pacing catheters
Measurement and imaging (FFR and OCT)
Peripheral dilatation catheters
Coronary dilatation catheters
Coronary and peripheral guidewires
Vessel closure/compression devices
Vascular access introducers
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 3784
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll subjects 18 years and older of all genders in which at least one Abbott target device specified in the CIP is used. Outcomes will be collected on any ancillary devices in scope, but patients will not be enrolled for use of an ancillary device without treatment with any target device. Patients must meet all general eligibility criteria and provide written informed consent or be enrolled under an IRB/EC approved waiver of consent, prior to sites' collection of patient data for the investigation.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
timeFrame: 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)
measure: Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
timeFrame: 30 days
measure: Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
timeFrame: 12 months
measure: Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
timeFrame: 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)
measure: Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
timeFrame: 30 days
measure: Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
timeFrame: 12 months
measure: Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR
timeFrame: 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)
measure: Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR
timeFrame: 30 days
measure: Peripheral Stents (Renal Indication) - Number of participants with composite of TLR
timeFrame: 12 months
measure: Pacing Catheters - Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)
timeFrame: 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)
measure: Pacing Catheters - Loss of capture (assessed based on physiological parameter-ECG)
timeFrame: 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)
measure: Vascular Plugs - Number of participants with composite of potential complications (Implant success, occlusion success, migration)
timeFrame: 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)
measure: Vascular Plugs - Number of participants with composite of occlusion success and migration
timeFrame: 30 days
measure: Fractional flow reserve - Number of participants with composite of vessel dissection, perforation, and thromboembolism
timeFrame: 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)
measure: Fractional flow reserve - Number of participants with signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03)
timeFrame: 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)
measure: Optical Coherence Tomography Products - Number of participants with Intraprocedural complications (number of dissections ≥type B, slow flow or no reflow, thrombus, abrupt closure, perforation)
timeFrame: 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)
measure: Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality pre-PCI
timeFrame: 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)
measure: Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality post-PCI
timeFrame: 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)
measure: Peripheral Dilatation Catheters - Number of participants with Composite of major adverse events
timeFrame: 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)
measure: Peripheral Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)
timeFrame: 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)
measure: Coronary Guidewires - Number of participants with Composite of major adverse events
timeFrame: 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)
measure: 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)
timeFrame: 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)
measure: Peripheral Guidewires - Number of participants with Composite of major adverse events
timeFrame: 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)
measure: 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)
timeFrame: 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)
measure: Coronary Dilatation Catheters - Number of participants with Composite of major adverse events
timeFrame: 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)
measure: Coronary Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)
timeFrame: 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)
measure: Vessel Closure Devices - Number of participants with Composite of access complications
timeFrame: 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)
measure: Vessel Closure Devices - Number of participants with Successful hemostasis Major and minor bleeding
timeFrame: 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)
measure: Vessel Compression Devices - Number of participants with Major and minor bleeding
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Vascular Access Introducers - Incidence of safety issues
timeFrame: 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)
measure: Vascular Access Introducers - Incidence of performance issues
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital - Univ. of Alabama at Birmingham (UAB)
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Nedlands
country: Australia
facility: Perth Institute of Vascular Research
state: WAUS
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: WAUS
city: Graz
country: Austria
facility: Universitätsklinik Graz
state: Styria
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis Campus Aalst
state: Eflndrs
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius Ziekenhuis
state: Eflndrs
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejian
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejian
city: Chartres
country: France
facility: CH Chartres
state: Centre
city: Paris
country: France
facility: Hôpital Paris Saint-Joseph
state: Ile
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum am Bethanien Krankenhaus
state: Hesse
city: Mainz
country: Germany
facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
state: Rhinela
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AÖR
state: Saxony
city: Bad Bevensen
country: Germany
facility: Herz- u. Gefäßzentrum Bad Bevensen
state: Saxon
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
state: Schlesw
city: Budapest
country: Hungary
facility: Semmelweis University
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombard
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
state: Lombard
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Catalon
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
state: Valncia
city: Madrid
country: Spain
facility: Hospital Universitario de la Paz
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
state: Basel
city: Bern
country: Switzerland
facility: Inselspital - University Hospital of Bern
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
state: Mtaiwan
city: Taipei City
country: Taiwan
facility: Cathay General Hospital
state: Ntaiwan
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
state: Staiwan
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital
state: Staiwan
city: Sharjah
country: United Arab Emirates
facility: Al Qassimi Hospital
Study officials:
affiliation: Abbott Medical Devices
name: Chananit Hutson, PhD
role: STUDY_DIRECTOR
References: