Abbott Vascular Medical Device Registry

Recruiting

• Conditions: Restenoses, Coronary; Coronary Artery Lesions; Arterial Embolism; Acute Myocardial Infarction; Venous Embolism
• Interventions: Device: Pacing catheters; Device: Measurement and imaging (FFR and OCT); Device: Vascular plugs; Device: Vessel closure/compression devices; Device: Coronary and peripheral stents; Device: Peripheral dilatation catheters; Device: Coronary and peripheral guidewires; Device: Coronary dilatation catheters; Device: Vascular access introducers

• Registration Number: NCT04573660
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-05
• Study Start: 2020-10-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18
• Primary Completion: 2030-11
• Study Completion: 2031-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3784

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pacing catheters	Pacing catheters	Participants in the Pacing catheters arm will receive Pacing catheters
Measurement and imaging (FFR and OCT)	Measurement and imaging (FFR and OCT)	Participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)
Vascular plugs	Vascular plugs	Participants in the Vascular plugs arm will receive Vascular plugs
Vessel closure/compression devices	Vessel closure/compression devices	Participants in the Vessel closure/compression devices arm will receive Vessel closure/compression devices
Coronary and peripheral stents	Coronary and peripheral stents	Participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
Peripheral dilatation catheters	Peripheral dilatation catheters	Participants in the Peripheral dilatation catheters arm will receive Peripheral dilatation catheters
Coronary and peripheral guidewires	Coronary and peripheral guidewires	Participants in the Coronary and peripheral guidewires arm will receive Coronary and peripheral guidewires
Coronary dilatation catheters	Coronary dilatation catheters	Participants in the Coronary dilatation catheters arm will receive Coronary dilatation catheters
Vascular access introducers	Vascular access introducers	Participants in the Vascular access introducers devices arm will receive Vascular access introducers

Primary Outcome Measures

Name	Time	Method
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR	12 months	Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality post-PCI	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)	Successful crossing and image quality post-PCI will be assessed among the patients who receive OCT.
Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR	30 days	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).
Peripheral Stents (Renal Indication) - Number of participants with composite of TLR	12 months	Composite of TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
Pacing Catheters - Loss of capture (assessed based on physiological parameter-ECG)	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)	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.
Vascular Plugs - Number of participants with composite of potential complications (Implant success, occlusion success, migration)	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)	Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive Vascular Plugs.
Vascular Plugs - Number of participants with composite of occlusion success and migration	30 days	Composite of occlusion success and migration will be assessed among the patients who receive Vascular Plugs.
Fractional flow reserve - Number of participants with composite of vessel dissection, perforation, and thromboembolism	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)	Composite of vessel dissection, perforation, and thromboembolism during procedure will be assessed among the patients who receive Fractional flow reserve (FFR).
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)	12 months	Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Pacing Catheters - Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)	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)	Composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) will be assessed among the patients who receive Pacing Catheters.
Fractional flow reserve - Number of participants with signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03)	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)	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.
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality pre-PCI	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)	Successful crossing and image quality pre- PCI will be assessed among the patients who receive OCT.
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)	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)	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.
Vessel Closure Devices - Number of participants with Composite of access complications	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)	Composite of access complications (e.g., hematoma, stenosis/occlusion, infection, access site bleeding) will be assessed among the patients who receive Vessel Closure Devices.
Optical Coherence Tomography Products - Number of participants with Intraprocedural complications (number of dissections ≥type B, slow flow or no reflow, thrombus, abrupt closure, perforation)	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)	Intraprocedural complications will be assessed among the patients who receive Optical Coherence Tomography (OCT).
Coronary Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)	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)	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.
Peripheral Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)	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)	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.
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)	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)	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.
Vessel Closure Devices - Number of participants with Successful hemostasis Major and minor bleeding	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)	Successful hemostasis Major and minor bleeding will be assessed among the patients who receive Vessel Closure Devices.
Peripheral Dilatation Catheters - Number of participants with Composite of major adverse events	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)	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.
Vascular Access Introducers - Incidence of safety issues	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)	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.
Coronary Guidewires - Number of participants with Composite of major adverse events	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)	Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Coronary Guidewires.
Peripheral Guidewires - Number of participants with Composite of major adverse events	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)	Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Peripheral Guidewires.
Coronary Dilatation Catheters - Number of participants with Composite of major adverse events	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)	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.
Vessel Compression Devices - Number of participants with Major and minor bleeding	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)	Major and minor bleeding will be assessed among the patients who receive Vessel Compression Devices.
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	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)	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.
Vascular Access Introducers - Incidence of performance issues	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)	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.

Trial Locations

Locations (36)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

Ningbo First Hospital; 🇨🇳 Ningbo, Zhejian, China

Centro Cardiologico Monzino; 🇮🇹 Milano, Lombard, Italy

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Catalon, Spain

Onze-Lieve-Vrouwziekenhuis Campus Aalst; 🇧🇪 Aalst, Eflndrs, Belgium

Hôpital Paris Saint-Joseph; 🇫🇷 Paris, Ile, France

Bryan Heart; 🇺🇸 Lincoln, Nebraska, United States

Cardioangiologisches Centrum am Bethanien Krankenhaus; 🇩🇪 Frankfurt, Hesse, Germany

Al Qassimi Hospital; 🇦🇪 Sharjah, United Arab Emirates

AZ Sint-Blasius Ziekenhuis; 🇧🇪 Dendermonde, Eflndrs, Belgium

CH Chartres; 🇫🇷 Chartres, Centre, France

Ospedale San Raffaele; 🇮🇹 Milano, Lombard, Italy

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

Wellmont CVA Heart Institute; 🇺🇸 Kingsport, Tennessee, United States

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz; 🇩🇪 Mainz, Rhinela, Germany

Kantonsspital Aarau; 🇨🇭 Aarau, Basel, Switzerland

Inselspital - University Hospital of Bern; 🇨🇭 Bern, Switzerland

National Cheng Kung University Hospital; 🇨🇳 Tainan City, Staiwan, Taiwan

Universitätsklinik Graz; 🇦🇹 Graz, Styria, Austria

Universitätsklinikum Leipzig AÖR; 🇩🇪 Leipzig, Saxony, Germany

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Utrecht, Netherlands

University Hospital - Univ. of Alabama at Birmingham (UAB); 🇺🇸 Birmingham, Alabama, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, WAUS, Australia

Perth Institute of Vascular Research; 🇦🇺 Nedlands, WAUS, Australia

Jinhua Municipal Central Hospital; 🇨🇳 Jinhua, Zhejian, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Herz- u. Gefäßzentrum Bad Bevensen; 🇩🇪 Bad Bevensen, Saxon, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel; 🇩🇪 Kiel, Schlesw, Germany

Semmelweis University; 🇭🇺 Budapest, Hungary

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Valncia, Spain

Hospital Universitario de la Paz; 🇪🇸 Madrid, Spain

Taichung Veterans General Hospital; 🇨🇳 Taichung, Mtaiwan, Taiwan

Cathay General Hospital; 🇨🇳 Taipei City, Ntaiwan, Taiwan

Chi Mei Hospital; 🇨🇳 Tainan City, Staiwan, Taiwan