LumiGuide for Aortic Aneurysm

(RadFree Trial)

Recruiting at 8 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

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable. Primary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)

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 data supports the effectiveness of the treatment LumiGuide for Aortic Aneurysm?

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 stent was successfully placed in a thoracic pseudoaneurysm with good recovery. Additionally, hybrid approaches combining surgical and endovascular techniques have been effective in treating complex aortic aneurysms with lower risks compared to traditional surgery. ^{1 2 3 4 5}

Is LumiGuide safe for use in humans?

Research on similar systems like fluoroscopy-guided procedures shows they are generally safe, but there are risks like radiation exposure. Safety measures, such as quality control and training, help prevent injuries. ^{6 7 8 9 10}

How does the LumiGuide treatment for aortic aneurysm differ from other treatments?

LumiGuide for aortic aneurysm is unique because it uses advanced imaging technology to guide the procedure, potentially offering more precise treatment compared to conventional fluoroscopy guidance. This approach may improve the accuracy and safety of the procedure by providing better visualization of the aneurysm and surrounding structures. ^{1 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Hybrid treatment of aortic aneurysms]. [2008]

2. England pubmed.ncbi.nlm.nih.gov

Post-traumatic thoracic pseudoaneurysm repair with an endoluminal expandable stent. [2016]

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

[Thoracic aortic aneurysms]. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Diagnosis and treatment of aortic diseases : new guidelines of the European Society of Cardiology 2014]. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Hybrid repair of an aortic arch aneurysm rupture in a redo sternotomy. [2016]

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

Feasibility of three-dimensional fusion imaging with multimodality roadmap system during endovascular aortic repair. [2018]

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

Early patient experience with an electro-anatomic navigation system dedicated to device lead implantation: feasibility and safety. [2019]

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

Managing uncertainty in complex interventional fluoroscopic procedures. [2014]

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

Three-Dimensional Holographic Guidance, Navigation, and Control (3D-GNC) for Endograft Positioning in Porcine Aorta: Feasibility Comparison With 2-Dimensional X-Ray Fluoroscopy. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Echo-endoscope biplane navigation system for endovascular aneurysm repair. [2016]

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

Wrapping of abdominal aortic aneurysms: a viable alternative. [2019]

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

Abdominal aortography. [2018]

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

Addition of a lateral view improves adequate visualization of the abdominal aorta during clinician performed ultrasound. [2016]

14. France pubmed.ncbi.nlm.nih.gov

[Contribution of imaging to the study of aortic aneurysms]. [2016]