Arcevo LSA for Aortic Arch Conditions

(ARTIZEN Trial)

Overseen By Erin M Adams, MSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Artivion Inc.

Disqualifiers: Pregnancy, Life expectancy < 2 years, Aortic stent graft, Infection, Renal disease, others

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

Compensation: Varies

Number of Visits: 31

Duration: Immediate post-procedure

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Arcevo LSA stent graft is a safe and effective treatment for individuals with specific aortic arch conditions. It targets those with an aortic dissection (a tear in the aorta wall) or an aneurysm (a bulge in the aorta) affecting the aortic arch and descending thoracic aorta. The trial includes two groups: one for chronic conditions and another for acute (sudden) or subacute (recent) issues. Suitable candidates have an aortic dissection or aneurysm involving the aortic arch and descending thoracic aorta, confirmed by a recent scan. As an unphased trial, this study provides patients the opportunity to contribute to medical research and potentially benefit from innovative treatment options.

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.

What prior data suggests that the Arcevo LSA stent graft is safe for treating aortic arch conditions?

Research shows that the Arcevo LSA stent graft is under careful study to assess its safety and effectiveness for treating aortic conditions. Specific information from past studies about side effects or patient tolerance is not yet available.

However, since this trial is not in the early stages, the treatment has already demonstrated some safety in humans. Treatments in later trial phases have typically undergone enough testing to indicate general safety, suggesting few serious side effects in earlier studies.

Prospective participants should ask the study team about any known risks and the measures in place to ensure participant safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for aortic arch conditions, which often involve open surgery or endovascular repair, Arcevo LSA offers a less invasive approach. Researchers are excited about Arcevo LSA because it targets aortic aneurysms and dissections with potentially fewer complications and shorter recovery times. This treatment uses a novel delivery system that can be especially beneficial for patients who are not ideal candidates for traditional surgery, providing a safer and more efficient alternative.

What evidence suggests that the Arcevo LSA stent graft is effective for aortic arch conditions?

Research has shown that the Arcevo LSA stent graft is being tested in this trial to treat serious aortic arch problems, such as tears or bulges in the main artery from the heart. The primary study arm will include participants with an aortic aneurysm or chronic aortic dissection, while the secondary study arm will include patients with acute or subacute aortic dissections. The stent graft acts as a support to strengthen the artery wall and prevent dangerous breaks. Although direct data on its effectiveness is limited, similar stent grafts have managed these issues successfully. The Arcevo LSA aims to improve patient outcomes by providing a strong and flexible solution for complex aortic repairs. Early signs are promising, but further research is needed to confirm its effectiveness. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with acute or chronic aortic dissection and/or aneurysm affecting the aortic arch and descending thoracic aorta, possibly including the ascending aorta. Specific eligibility criteria are not provided.

Inclusion Criteria

The diameter of my aorta where it connects is 21 mm or more.

The part of my aorta to be sealed is 20-36 mm wide.

I am between 18 and 80 years old.

Exclusion Criteria

Patient has a medical, social, or psychological problem that could impede the patient's ability to return for follow-up

Patient is pregnant, or planning to become pregnant during the course of the study; individuals of child-bearing potential must agree to use acceptable methods of contraception during the study

Patient has an existing aortic stent graft device in the descending aorta that would interact with Arcevo™ LSA

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Arcevo LSA stent graft for the treatment of aortic arch aneurysms and dissections

Immediate post-procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months

Extension

Participants may require additional thoracic extension procedures if necessary

30 days post-extension procedure

What Are the Treatments Tested in This Trial?

Interventions

• Arcevo LSA

Trial Overview The Arcevo LSA Hybrid Stent Graft System is being tested to see if it's safe and effective in treating conditions involving the aortic arch and descending thoracic aorta.

How Is the Trial Designed?

Group I: Arcevo LSA Experimental Treatment 1 Intervention

The Primary study arm will consist of patients with an aortic aneurysm or chronic aortic dissection (n=117). The Secondary study arm will include patients with acute or subacute aortic dissections (n=15).

Who Is Running the Clinical Trial?

Artivion Inc.

Lead Sponsor

Trials

7

Recruited

1,500+

Bright Research Partners

Industry Sponsor

Trials

18

Recruited

2,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07089576

NCT07089576 | Clinical Study to Evaluate the Safety and ... The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or ...

2. investors.artivion.com investors.artivion.com/news-releases/news-release-details/artivion-announces-treatment-first-patient-arcevo-lsa-artizen

Artivion Announces Treatment of First Patient with Arcevo LSA ... The ARTIZEN trial is a prospective, multicenter, non-randomized clinical trial evaluating the safety and effectiveness of Arcevo LSA in the ...

3. prnewswire.com prnewswire.com/news-releases/artivion-announces-treatment-of-first-patient-with-arcevo-lsa-in-artizen-pivotal-trial-302606901.html

Artivion Announces Treatment of First Patient with Arcevo ... The ARTIZEN trial is a prospective, multicenter, non-randomized clinical trial evaluating the safety and effectiveness of Arcevo LSA in the ...

4. trial.medpath.com trial.medpath.com/clinical-trial/9dbf6c36eae2a890/nct07089576-arcevo-lsa-safety-effectiveness-aortic-arch-aneurysms-dissections

Clinical Study to Evaluate the Safety and Effectiveness of ... The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or ...

5. patlynk.com patlynk.com/trial/NCT07089576

Arcevo LSA for Aortic Arch Aneurysms and Dissections ... Study AimThis clinical trial is investigating the safety and effectiveness of Arcevo LSA for treating aortic arch aneurysms and dissections.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07089576

NCT07089576 | Clinical Study to Evaluate the Safety and ... The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or ...

7. medicaldevice-network.com medicaldevice-network.com/news/artivion-arcevo-lsa/

Artivion treats first subject in trial of Arcevo LSA stent graft Participants included in the trial have been diagnosed with either aortic dissection or aneurysm involving the aortic arch. November 7, 2025.