Medical Devices for Coronary Artery Disease

(AV-MDR Trial)

Recruiting at 39 trial locations

Overseen By Chinedu Agbonghai, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Covid-19, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

3784 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and performance of various medical devices used in heart and blood vessel procedures. The focus includes tools like stents (such as the Absolute Pro LL stent), catheters, and imaging devices to ensure they function effectively and do not introduce new risks. Individuals who have undergone or are planning to undergo a procedure using one of these devices might be suitable for this trial. Participants must follow up as required and provide written consent to join. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the availability of these important medical devices.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these devices are safe?

Research shows that coronary and peripheral stents are generally safe and effective, though they carry some risks. Some studies mention concerns like late-stent thrombosis, a blood clot inside the stent, and bleeding events. However, these devices are minimally invasive, making them a preferred choice for many patients.

For tools like FFR (Fractional Flow Reserve) and OCT (Optical Coherence Tomography), studies have shown they are safe to use. They provide clear and reliable images, aiding doctors in making better decisions about heart health.

Vessel closure devices, used to close blood vessels after a procedure, have a good safety record, though some data is mixed. While effective, there is a chance of complications like device failure.

Coronary dilatation catheters have not been fully proven safe in all types of blood vessels, but doctors trained in specific heart procedures often use them.

Vascular plugs, mainly used to block abnormal blood flow, are considered safe but can cause issues like a hematoma, a swelling of clotted blood, at the entry site.

Peripheral dilatation catheters, used to widen blood vessels, should be used with caution, especially in vessels with hard, calcified buildup.

Pacing catheters, which help manage heartbeats, can be risky if not inserted correctly. They require careful handling to avoid damage.

Coronary and peripheral guidewires, which help guide other devices into place, are safe when undamaged. Using a faulty guidewire can lead to vessel damage.

Lastly, vascular access introducers, which help insert other devices into the body, are generally safe, but bleeding or infection can occur.

Overall, these devices are widely used and generally safe, but each comes with its own set of risks. Always discuss these with a doctor to understand what they mean for your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Abbott Vascular Medical Device Registry trial because it's exploring a wide range of innovative devices that could revolutionize how we address coronary and peripheral artery conditions. Unlike standard treatments that might just rely on traditional stents and catheters, this trial examines advanced options like the XIENCE PRIME BTK stent, which is designed specifically for below-the-knee arteries, potentially offering better outcomes for patients with complex blockages. Additionally, technologies like FFR and OCT provide real-time measurement and imaging, giving doctors precise insights into blood flow and artery conditions, allowing for more tailored treatment. The trial also includes cutting-edge vessel closure and compression devices, which can enhance recovery times and reduce complications after procedures. These advancements could significantly improve patient care by offering more personalized and effective treatment options.

What evidence suggests that this trial's treatments could be effective?

This trial will evaluate various devices to improve patient outcomes in cardiovascular procedures. Participants will be assigned to different arms, each focusing on a specific device.

Studies have shown that stents, small tubes placed in arteries, can improve blood flow in blocked arteries. Participants in the "Coronary and peripheral stents" arm will receive these stents. However, stents do not always reduce the risk of death from heart disease in stable patients.

Research suggests that using special tools like FFR and OCT, which participants in the "Measurement and imaging (FFR and OCT)" arm will receive, can provide doctors with a clearer view of artery blockages, leading to better treatment choices.

Devices that close blood vessels after procedures, included in the "Vessel closure/compression devices" arm, have been very successful, aiding faster recovery and reducing discomfort.

Catheters used to widen blood vessels, part of the "Coronary dilatation catheters" and "Peripheral dilatation catheters" arms, generally improve blood flow during procedures.

Vascular plugs, which block unwanted blood flow in veins and are part of the "Vascular plugs" arm, are effective and pose a low risk of complications.

Each of these devices has shown promise in improving patient outcomes in their specific applications. ^{6 7 8 9 10}

Who Is on the Research Team?

Chananit Hutson, PhD

Principal Investigator

Abbott Medical Devices

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject has a planned procedure, or underwent a procedure, that will use/used one or more Abbott target devices covered in this registry.

Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo procedures involving various medical devices such as stents, catheters, and imaging tools. The procedure starts when a guidewire enters the vasculature and ends with vessel closure.

During procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including assessment of device performance and any adverse events.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Absolute Pro LL stent
• AVP 4
• AVP I
• AVP II
• Coronary and peripheral guidewires
• Coronary and peripheral stents
• Coronary dilatation catheters
• Measurement and imaging (FFR and OCT)
• MULTI-LINK 8 LL stent
• MULTI-LINK 8 stent
• MULTI-LINK 8 SV stent
• Pacel BPC
• Pacel FDPC
• Pacing catheters
• Peripheral dilatation catheters
• PressureWire X
• Supera 7.5 OD stent
• Vascular access introducers
• Vascular plugs
• Vessel closure/compression devices
• XIENCE PRIME BTK stent
• Xpert Pro stent

How Is the Trial Designed?

Group I: Vessel closure/compression devices Experimental Treatment 1 Intervention

Participants in the Vessel closure/compression devices arm will receive Vessel closure/compression devices

Group II: Vascular plugs Experimental Treatment 1 Intervention

Participants in the Vascular plugs arm will receive Vascular plugs

Group III: Vascular access introducers Experimental Treatment 1 Intervention

Participants in the Vascular access introducers devices arm will receive Vascular access introducers

Group IV: Peripheral dilatation catheters Experimental Treatment 1 Intervention

Participants in the Peripheral dilatation catheters arm will receive Peripheral dilatation catheters

Group V: Pacing catheters Experimental Treatment 1 Intervention

Participants in the Pacing catheters arm will receive Pacing catheters

Group VI: Measurement and imaging (FFR and OCT) Experimental Treatment 1 Intervention

Participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)

Group VII: Coronary dilatation catheters Experimental Treatment 1 Intervention

Participants in the Coronary dilatation catheters arm will receive Coronary dilatation catheters

Group VIII: Coronary and peripheral stents Experimental Treatment 1 Intervention

Participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents

Group IX: Coronary and peripheral guidewires Experimental Treatment 1 Intervention

Participants in the Coronary and peripheral guidewires arm will receive Coronary and peripheral guidewires

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.124.014529

Enhancing Guidewire Efficacy for Transradial Access Our trial demonstrated a higher overall technical failure rate (10% overall, 16% in the control arm) but higher final rates of transradial ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39215512/

Enhancing Guidewire Efficacy for Transradial Access Conclusions: A narrow 1.5 mm J-tipped hydrophilic guidewire resulted in greater technical success and reduced fluoroscopy time compared with the ...

3. jacc.org jacc.org/doi/10.1016/j.jcin.2018.12.014

First Report of Outcomes of the 3-Dimensional Wiring ... The results of this study demonstrated that the overall success rate was significantly increased after the introduction of 3D wiring because ...

4. scholarlycommons.henryford.com scholarlycommons.henryford.com/cgi/viewcontent.cgi?article=1816&context=cardiology_articles

Safety and efficacy of dedicated guidewire, microcatheter, ... Safety and efficacy of dedicated guidewire, microcatheter, and guide catheter extension technologies for chronic total coronary occlusion.

5. uscjournal.com uscjournal.com/articles/guidewires-expert-round-table?language_content_entity=en

Guidewires - Expert Round Table On average I use 2.1 guidewires per case, with 1.4 multivessel and 2.2 lesions per PCI. The BMW wire could be used in multiple lesions and multivessels by ...

6. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/peripheral-intervention/guide-wires/important-safety-information.html

Peripheral Guide Wires Important Safety Information Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response. Confirm the compatibility of the ...

7. bostonscientific.com bostonscientific.com/en-US/products/guidewires/sentai-guidewires/sentai-guidewires-indications-safety-and-warnings.html

SENTAI Guidewires Indications, Safety and Warnings SENTAI™ Guidewires - Indications, Safety and Warnings · Do not use a guidewire that has been damaged. · Use the device prior to the “Use By” date noted on the ...

8. fda.gov fda.gov/media/113959/download

Coronary, Peripheral, and Neurovascular Guidewires This guidance document provides recommendations for premarket notification (510(k)) submissions for guidewires intended for use in the coronary ...

9. merit.com merit.com/wp-content/uploads/2023/11/InQwire-SSCP0072_004.pdf

Summary of Safety and Clinical Performance (SSCP) Safety data for the IQ Diagnostic Guide Wire from the. PMCF, and for comparable benchmark guidewires from the clinical literature are summarized in Table 12.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4669307/

Safety of guidewire-based measurement of fractional flow ... Coronary guidewire-based diagnostic assessments with hyperemia may cause iatrogenic complications. We assessed the safety of guidewire-based measurement of ...