LumiGuide for Aortic Aneurysm

(RadFree Trial)

Recruiting at 9 trial locations

Overseen By Bart Wessels

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Philips Clinical & Medical Affairs Global

Disqualifiers: Connective tissue disorders, Contrast allergies, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Procedure time

182 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist doctors in performing Fenestrated Endovascular Aortic Repair (FEVAR), a surgery that addresses issues in the main blood vessel from the heart. It compares a new guidance tool, LumiGuide, with the traditional method, Conventional Fluoroscopy Guidance, to determine if LumiGuide reduces the time doctors need to use X-rays during surgery. Individuals requiring a FEVAR procedure and having issues with specific arteries might be suitable candidates. Participants should not have allergies to contrast dye or certain genetic disorders, and they must be able to provide informed consent. As an unphased trial, this study allows participants to contribute to innovative surgical advancements that could enhance future procedures.

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 LumiGuide is safe for use in FEVAR procedures?

Research has shown that LumiGuide technology is safe for use in medical procedures. Philips, the company behind LumiGuide, received FDA approval for its guidewire, which has treated over 1,000 patients, indicating a strong safety record. Additionally, early results from other studies suggest that the technology enhances the safety and effectiveness of complex procedures. Although specific side effects are not listed, these approvals and findings suggest that LumiGuide is well-tolerated by patients undergoing procedures with this technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LumiGuide because it offers a new way to navigate aortic aneurysm procedures with enhanced precision. Unlike conventional fluoroscopy guidance, LumiGuide provides a more detailed and real-time view, which can help surgeons perform the operation with greater accuracy. This could potentially lead to safer surgeries and better outcomes for patients, reducing the risk of complications associated with traditional methods. By improving how surgeons visualize the aneurysm and surrounding areas, LumiGuide aims to make these complex procedures easier and more effective.

What evidence suggests that LumiGuide is effective for reducing fluoroscopy time in aortic aneurysm repair?

Research has shown that LumiGuide, a tool studied in this trial for aortic aneurysm repair, uses light instead of traditional X-rays to guide the procedure. This technology may enhance safety by reducing radiation exposure. Participants in this trial will receive either standard care with LumiGuide or conventional fluoroscopy guidance. One study found that similar methods using X-rays successfully placed stents for aortic aneurysms. This suggests LumiGuide could be effective, as it aims to provide clearer views inside the body. While these results are encouraging, further studies are needed to confirm its long-term effectiveness. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who will undergo a primary FEVAR procedure, including those with prior infrarenal EVAR or open repair. Participants should have at least a 2-year life expectancy and be able to give informed consent. It's not specified who can't join the trial.

Inclusion Criteria

Subject has a life expectancy of at least 2 years

I am scheduled for a specific aortic repair surgery involving the arteries near my stomach.

My treatment involves the celiac trunk, superior mesenteric artery, and renal arteries.

Exclusion Criteria

Subject with contrast allergies

Subject participates in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials may be allowed provided that pre-approval is obtained from Philips

Subject unwilling or unable to comply with the protocol unable to understand verbal and/or written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Fenestrated Endovascular Aortic Repair (FEVAR) using either LumiGuide or conventional fluoroscopy guidance

Procedure time

Follow-up

Participants are monitored for safety and effectiveness after the FEVAR procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Fluoroscopy Guidance
• LumiGuide

Trial Overview The study compares average fluoroscopy time during FEVAR procedures using LumiGuide versus conventional guidance. The goal is to show that LumiGuide reduces exposure time. This multi-center study includes various geographic locations for broader applicability.

How Is the Trial Designed?

Group I: Task navigation using LumiGuide Active Control 1 Intervention

Standard of care treatment using LumiGuide fluoroscopy guidance

Group II: Task navigation using fluoroscopy guidance Active Control 1 Intervention

Standard of care treatment using

Who Is Running the Clinical Trial?

Philips Clinical & Medical Affairs Global

Lead Sponsor

Trials

61

Recruited

17,600+

Roy Jakobs

Philips Clinical & Medical Affairs Global

Chief Executive Officer since 2022

MBA from Erasmus University Rotterdam

Carla Goulart Peron

Philips Clinical & Medical Affairs Global

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

1. withpower.com withpower.com/trial/phase-aortic-aneurysm-8-2024-d539d

LumiGuide for Aortic Aneurysm (RadFree Trial) The use of fluoroscopic guidance, similar to LumiGuide, has been shown to be effective in deploying stents for aortic aneurysms, as seen in a case where a ...

2. uabmedicine.org uabmedicine.org/news/uab-surgery-introduces-lumiguide-by-fors-revolutionizing-aneurysm-repair-procedures/

UAB Surgery introduces LumiGuide in aneurysm repair ... This is an advanced internal device visualization solution utilizing light technology for navigation inside blood vessels without the use of fluoroscopy.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1856532/

Long-term Outcomes After Endovascular Abdominal Aortic ... Cumulative survival was 52% at 5 years. Conclusions: EVAR using contemporary devices is a safe, effective, and durable method to prevent AAA rupture and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31515176/

Five-year results of endovascular abdominal aortic ... Technical success was 99.7%. Thirty-day mortality was 0.3%, 30-day rate of major adverse event was 1.6%, and polymer leak rate was 0.2%. Freedom from type IA ...

5. evtoday.com evtoday.com/articles/2017-mar/true-long-term-results-what-have-we-learned

True Long-Term Results: What Have We Learned? Twelve years after randomization, the cumulative overall survival rates were 42.2% after open repair and 38.5% after endovascular repair (difference, 3.7%; 95% ...

6. usa.philips.com usa.philips.com/a-w/about/news/archive/standard/news/press/2024/philips-announces-fda-approval-for-enhanced-lumiguide-guidewire-and-marks-the-1000th-patient-treated-with-its-breakthrough-3d-device-guidance-technology.html

Enhanced LumiGuide guidewire - News Philips' new 160cm (63 inch) LumiGuide wire enables US physicians to experience 3D device guidance with more catheters than before.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10686527/

FACTORS INFLUENCING FLUOROSCOPY TIME IN ... The objectives of this study were to document fluoroscopy time (FT) during EVAR and identify possible factors that influence it.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0895796721000582

Fiber Optic RealShape technology in endovascular surgery Early findings demonstrate the technology to be safe and effective in offsetting procedural complexity. Research and development to improve rendering accuracy ...