Endovascular Graft + Bridging Stent for Aortic Aneurysm

Not currently recruiting at 35 trial locations

Overseen By Maria Soerensen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cook Research Incorporated

Disqualifiers: Age < 18, Life expectancy < 2 years, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Procedure day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to treat aortic aneurysms, dangerous bulges in the aorta, the body's main blood vessel. The study evaluates the safety and effectiveness of the Zenith Fenestrated+ Endovascular Graft, an endovascular device, used with a special stent to repair these aneurysms. It focuses on aneurysms affecting major arteries, which can be life-threatening if untreated. Individuals with an aortic aneurysm that has grown quickly or is larger than normal might be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

Do I need to stop my current medications for this 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 the Zenith® Fenestrated+ Endovascular Graft and BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System are safe for treating aortic aneurysms?

Research has shown that the Zenith Fenestrated+ Endovascular Graft is safe for treating aortic aneurysms. A long-term study found no deaths related to the graft or aneurysm over five years, indicating it is well-tolerated by patients. The graft forms a strong seal to control the aneurysm and reduce the risk of complications. While this trial tests the combination of this graft with another device, existing data on the Zenith Fenestrated+ alone is promising for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Zenith Fenestrated+ Endovascular Graft is unique because it offers a tailored approach to treating aortic abdominal aneurysms. Unlike traditional open surgery or standard endovascular repair, this treatment uses a fenestrated graft that can be customized to fit the unique anatomy of each patient’s aorta. Researchers are excited because this personalized fit can potentially reduce complications and improve outcomes by providing a more precise repair, especially in complex cases where standard treatments may not be as effective.

What evidence suggests that the Zenith Fenestrated+ Endovascular Graft is effective for aortic aneurysms?

Research has shown that the Zenith Fenestrated+ Endovascular Graft, which participants in this trial may receive, effectively treats aortic aneurysms. A study with results over five years confirmed its safety and success, with no deaths linked to the graft or aneurysm. The device creates a strong seal, keeping blood away from the aneurysm. This treatment precisely targets aortic aneurysms involving major blood vessels. Overall, the Zenith Fenestrated+ has demonstrated strong success in clinical settings. ^{1 2 3 4 6}

Who Is on the Research Team?

Gustavo Oderich, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with large or rapidly growing aortic aneurysms near the major arteries from the chest to the abdomen. Candidates must not be pregnant, planning pregnancy within 5 years, or involved in other studies. They should expect to live more than 2 years and agree to follow-up visits.

Inclusion Criteria

I have a large or saccular aneurysm in my chest or abdomen that needs treatment.

My aortic aneurysm is 50 mm or larger.

My aortic aneurysm has grown 5 mm or more in 6 months.

Exclusion Criteria

You are not expected to live more than 2 years.

I cannot or will not give my consent to participate.

Pregnant, breast-feeding, or planning to become pregnant within 60 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Zenith® Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 for the treatment of aortic aneurysms

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of device technical success and procedural safety

30 days

1 visit (in-person)

Long-term Follow-up

Participants are monitored for freedom from aneurysm-related mortality and clinically significant reintervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Zenith Fenestrated+ Endovascular Graft

Trial Overview The study tests the Zenith® Fenestrated+ Endovascular Graft combined with BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System on patients with complex aortic aneurysms, evaluating its safety and effectiveness in treating these conditions.

How Is the Trial Designed?

Group I: Aortic abdominal aneurysm Experimental Treatment 1 Intervention

Zenith Fenestrated+ Endovascular Graft is already approved in United States, European Union for the following indications:

Approved in United States as Zenith Fenestrated AAA Endovascular Graft for:

• Abdominal aortic aneurysms (AAAs) in high-risk patients who are not suitable for conventional open surgical repair or who are not suitable for repair with a standard Zenith Endovascular Graft

Approved in European Union as Zenith Fenestrated AAA Endovascular Graft for:

• Abdominal aortic aneurysms (AAAs) in high-risk patients who are not suitable for conventional open surgical repair or who are not suitable for repair with a standard Zenith Endovascular Graft

Who Is Running the Clinical Trial?

Cook Research Incorporated

Lead Sponsor

Trials

31

Recruited

254,000+

Published Research Related to This Trial

The Cobra PzF coronary stent demonstrated safety and efficacy in a multicenter study involving 940 patients, achieving a primary endpoint of major adverse cardiac events (MACE) in only 9% of cases after one year.

Definite stent thrombosis was very low at 0.7%, indicating that the Cobra PzF stent is a promising option for patients requiring short dual antiplatelet therapy (DAPT) or mono antiplatelet therapy (MAPT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the safety and efficacy of the Cobra PzF NanoCoated coronary stent in routine, consecutive, prospective, and high-risk patients: The e-Cobra study. Maillard, L., de Labriolle, A., Brasselet, C., et al.[2022]

In a study of 370 patients, the unrestricted use of the Resolute zotarolimus-eluting stent (ZES) showed a low rate of major adverse cardiac events (MACE) at 8.5% over a mean follow-up of 17.3 months, indicating its safety in clinical practice.

Off-label use of the Resolute ZES did not increase the risk of MACE compared to on-label use, suggesting that it can be safely used in a broader range of patients without compromising outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unrestricted use of endeavor resolute zotarolimus-eluting stent in daily clinical practice: a prospective registry. Galasso, G., Piccolo, R., Cassese, S., et al.[2019]

The Zenith fenestrated stent graft system is a custom-designed device approved for treating complex aortic aneurysms, specifically for patients with short-neck infrarenal and juxtarenal abdominal aortic aneurysms.

In a case study of an 80-year-old female patient, the stent graft was successfully implanted using a totally percutaneous approach, resulting in no complications and a follow-up CT scan at 12 months showing no endoleak or graft issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical aspects of repair of juxtarenal abdominal aortic aneurysms using the Zenith fenestrated endovascular stent graft. Oderich, GS., Correa, MP., Mendes, BC.[2016]

Between April 2012 and August 2015, the Zenith fenestrated endovascular graft (ZFEN) saw a remarkable 911% increase in monthly orders, indicating growing adoption among trained physicians, with 388 out of 553 trained physicians ordering a total of 2669 devices.

Despite the increase in orders, a significant number of trained physicians (30%) did not order any devices, and 81% ordered five or fewer per year, suggesting that the use of this complex technology may be better suited for high-volume centers to ensure optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in use of the only Food and Drug Administration-approved commercially available fenestrated endovascular aneurysm repair device in the United States. Simons, JP., Shue, B., Flahive, JM., et al.[2019]

The Zenith Fenestrated Endovascular Graft (ZFEN) shows significantly lower rates of perioperative mortality (1.8% vs 8.8%) and postoperative renal dysfunction (1.4% vs 7.7%) compared to open complex abdominal aortic aneurysm (AAA) repair, based on a study of 6825 AAA repairs.

When compared to standard infrarenal endovascular aneurysm repair (EVAR), ZFEN has similar rates of perioperative mortality and complications, indicating it is a safe and effective alternative for complex AAAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated endovascular aneurysm repair is associated with lower perioperative morbidity and mortality compared with open repair for complex abdominal aortic aneurysms. Varkevisser, RRB., O'Donnell, TFX., Swerdlow, NJ., et al.[2019]

The COBRA PzF Coronary Stent System is designed to reduce inflammation and improve thrombo-resistance, making it suitable for patients at high risk for bleeding events, such as those with atrial fibrillation.

In a reported case, this stent allowed for a successful treatment with a shorter duration of dual antiplatelet therapy while also aiming to lower the risk of restenosis, which is the re-narrowing of the artery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case report of the new Polyzene™-F COBRA PzF™ Nanocoated Coronary Stent System (NCS): Addressing an unmet clinical need. Styllou, P., Silber, S.[2017]

In a study of 121 patients undergoing fenestrated endovascular repair with the Zenith® Fenestrated stent-graft, relocating struts for superior mesenteric artery (SMA) incorporation did not negatively affect procedural success or midterm outcomes, with an overall technical success rate of 99%.

Patients with strut relocation experienced lower operative times and reduced contrast volume and radiation exposure, suggesting that this approach may enhance procedural efficiency without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superior mesenteric artery outcomes after large fenestration strut relocation with the Zenith Fenestrated endoprosthesis. Mirza, AK., Sullivan, TM., Skeik, N., et al.[2020]

In a study of 100 patients treated with the Zenith Fenestrated (ZFEN) aortic stent graft system, technical success was achieved in 98% of cases, indicating high efficacy for endovascular aneurysm repair.

The study reported a 2% perioperative mortality rate and a 20% rate of reintervention during follow-up, highlighting the importance of close monitoring for complications such as stent thrombosis and endoleaks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Institutional experience with the Zenith Fenestrated aortic stent graft. Wang, SK., Gutwein, AR., Gupta, AK., et al.[2018]

In a study of 44 STEMI patients, zotarolimus-eluting stents (ZES) showed no significant difference in the percentage of uncovered struts compared to bare-metal stents (BMS) at 6 months, indicating similar healing properties.

Both ZES and BMS demonstrated comparable neointimal responses and no late acquired malapposition, suggesting that ZES is as safe and effective as BMS in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (Optical Coherence Tomography in Acute Myocardial Infarction) Study. Guagliumi, G., Sirbu, V., Bezerra, H., et al.[2016]

Using a fenestrated endograft configuration with a large fenestration for the superior mesenteric artery (SMA) and two small fenestrations for the renal arteries significantly increases the proximal seal length, which can help prevent complications like type IA endoleaks.

In a study of 100 patients, the new configuration (B) was associated with a 5.8 mm gain in seal zone length compared to the traditional configuration (A), and type IA endoleaks were resolved without intervention in all cases, indicating a safe and effective approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing proximal seal zone in fenestrated endografting: Evolution in the approach to graft configuration. Newton, DH., Etkin, Y., Foley, PJ., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32891806/

Final 5-year results of the United States Zenith Fenestrated ... These 5-year results confirm the safety and effectiveness of the Zenith Fenestrated AAA stent graft with no late graft- or aneurysm-related deaths.

2. cookmedical.com cookmedical.com/newsroom/final-patient-treated-in-zenith-fenestrated-endovascular-graft-clinical-study/

Final patient treated in ZENITH® FENESTRATED+ ... Overall, the ZFEN+ allows for the endovascular treatment of patients with aortic aneurysms and maximizes the seal zone to exclude the aneurysm.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04875429

NCT04875429 | Zenith® Fenestrated+ Clinical Study Study Overview. Brief Summary. The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ ...

4. pennmedicine.org pennmedicine.org/physicians-hub/clinical-briefing/enrolling-clinical-trials-zfen-stent-graft-for-visceral-artery-aneurysm-repair

Enrolling clinical trials: ZFEN+ stent graft | Clinical Briefing The Zenith Unibody2 Endovascular Graft is indicated for the endovascular treatment of patients with abdominal or thoracoabdominal aortic ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf2/p020018s040b.pdf

Summary of Safety and Effectiveness Data - accessdata.fda.gov Table 22 reports the technical success results for the Zenith. Fenestrated AAA Endovascular Graft. Table 22. Technical success. Measure.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02577562

Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) ... The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the ...