GPX® Embolic Device for Embolism

(GPX Trial)

Recruiting at 15 trial locations

Overseen By Michelle Doyle, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fluidx Medical Technology, Inc.

Disqualifiers: Pregnancy, Infections, Drug dependency, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During procedure

114 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

How is the GPX® Embolic Device treatment different from other treatments for embolism?

The GPX® Embolic Device is unique because it is specifically designed to block blood flow in targeted areas, which can help manage embolism by preventing further clot movement. Unlike traditional drug treatments that focus on dissolving clots, this device physically obstructs blood flow, offering a novel approach to embolism management. ^{1 2 3 4 5}

What is the purpose of this trial?

The objective of this study is to evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal vessel penetration in 114 subjects in up to 25 investigational sites in the USA, New Zealand, and Canada.

Research Team

Michael Darcy, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults over 18 with certain vascular tumors like kidney cancer or bone tumors, who need a procedure to block blood flow to these areas. They must expect to live at least another month and be able to follow the study's procedures.

Inclusion Criteria

I have given my permission for treatment or my legal representative has.

My doctor believes I will live more than 30 days after my procedure.

I have a tumor that is related to the blood vessels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo distal embolization in the peripheral vasculature using the GPX® Embolic Device

During procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• GPX® Embolic Device

Trial Overview The GPX® Embolic Device is being tested for its safety and effectiveness in blocking blood vessels that feed tumors. The study will involve up to 114 participants across sites in the USA, New Zealand, and Canada.

Participant Groups

Group I: GPX® Embolic Device Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Fluidx Medical Technology, Inc.

Lead Sponsor

Trials

1

Recruited

110+

Bright Research Partners

Industry Sponsor

Trials

18

Recruited

2,700+

Findings from Research

In the CHAMPION PHOENIX trial, only 3.5% of the 10,942 patients required bailout glycoprotein IIb/IIIa inhibitors (GPI) for thrombotic complications, but those who did faced significantly higher risks of serious outcomes, including death and myocardial infarction, with a 19.2% incidence compared to 4.8% in non-GPI patients.

Patients receiving GPI also had a higher rate of severe or moderate bleeding (2.6% vs 0.4%), indicating that while GPI can be used in emergencies, it may lead to increased complications, suggesting that preventing thrombotic issues during procedures is a better strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and outcomes of patients requiring bailout use of glycoprotein IIb/IIIa inhibitors for thrombotic complications of percutaneous coronary intervention: An analysis from the CHAMPION PHOENIX trial. Abtan, J., Ducrocq, G., Steg, PG., et al.[2019]

In a case study of a 73-year-old man with a right middle cerebral artery occlusion, early detection of reocclusion was achieved using transcranial Doppler monitoring after endovascular clot aspiration, highlighting the importance of continuous monitoring in stroke management.

The administration of the GPIIb-IIIa antagonist abciximab under ultrasound monitoring led to successful recanalization of distal occlusions, resulting in significant clinical improvement and no hemorrhagic complications, suggesting that this approach may enhance outcomes in similar cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arterial reocclusion and persistent distal occlusion after thrombus aspiration. Zhao, L., Rubiera, M., Harrigan, MR., et al.[2012]

Platelet GP IIb/IIIa receptor antagonists (GPAs) have been shown to effectively reduce ischemic complications in over 33,000 patients across 11 large trials, particularly during high-risk coronary interventions and in conditions like myocardial infarction and unstable angina.

These medications, including abciximab, eptifibatide, and tirofiban, are generally well tolerated and safe when used alongside other antithrombotics, as long as platelet counts are monitored and their use is carefully managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current knowledge of the platelet glycoprotein IIb/IIIa receptor antagonists for the treatment of coronary artery disease. Berkowitz, SD.[2018]

In a study of 1,392 octogenarians undergoing percutaneous coronary intervention (PCI), the use of glycoprotein IIb/IIIa receptor inhibitors (GPI) was linked to a higher incidence of bleeding complications, but did not significantly increase the need for blood transfusions or the risk of intracranial hemorrhage.

Despite being associated with longer hospital stays, GPI treatment in octogenarians did not independently predict mortality, suggesting that while there are risks, the overall safety profile remains acceptable for this age group undergoing PCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous coronary interventions in octogenarians. glycoprotein IIb/IIIa receptor inhibitors' safety profile. Sadeghi, HM., Grines, CL., Chandra, HR., et al.[2019]

The small-molecule tracer 18F-GP1 shows high affinity for GPIIb/IIIa receptors, which are crucial for platelet aggregation, making it a promising tool for PET imaging of thrombi in various thromboembolic diseases.

In preclinical studies with cynomolgus monkeys, 18F-GP1 demonstrated rapid blood clearance and a high clot-to-blood ratio, allowing for effective detection of small thrombi and emboli, and it is now being evaluated in human clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-GP1, a Novel PET Tracer Designed for High-Sensitivity, Low-Background Detection of Thrombi. Lohrke, J., Siebeneicher, H., Berger, M., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Characteristics and outcomes of patients requiring bailout use of glycoprotein IIb/IIIa inhibitors for thrombotic complications of percutaneous coronary intervention: An analysis from the CHAMPION PHOENIX trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Arterial reocclusion and persistent distal occlusion after thrombus aspiration. [2012]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Current knowledge of the platelet glycoprotein IIb/IIIa receptor antagonists for the treatment of coronary artery disease. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Percutaneous coronary interventions in octogenarians. glycoprotein IIb/IIIa receptor inhibitors' safety profile. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

18F-GP1, a Novel PET Tracer Designed for High-Sensitivity, Low-Background Detection of Thrombi. [2018]