Endovascular Graft + Bridging Stent for Aortic Aneurysm

Recruiting at 30 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

102 Participants Needed

Trial Summary

What is the purpose of this trial?

The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.

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 data supports the effectiveness of the treatment Zenith Fenestrated+ Endovascular Graft for aortic aneurysm?

Research shows that the Zenith Fenestrated Endovascular Graft is associated with lower complications and death rates compared to traditional open surgery for complex abdominal aortic aneurysms. Additionally, patients have been successfully treated with this graft, experiencing no complications and good outcomes up to a year after the procedure. ^{1 2 3 4 5}

What safety data exists for the Zenith Fenestrated aortic stent graft?

The Zenith Fenestrated aortic stent graft has been used in 100 patients from 2012 to 2017, indicating it has been applied in real-world settings, which suggests some level of safety in humans. ^{6 7 8 9 10}

How is the Zenith Fenestrated+ Endovascular Graft treatment different from other treatments for aortic aneurysm?

The Zenith Fenestrated+ Endovascular Graft is unique because it is a custom-made, patient-specific device designed to treat complex aortic aneurysms by allowing for a precise fit and sealing in the aorta, which can reduce the risk of complications compared to traditional open surgery. It is the only FDA-approved fenestrated device in the U.S., offering a minimally invasive option for patients with challenging aneurysm anatomies. ^{1 2 3 4 5}

Research Team

Gustavo Oderich, MD

Principal Investigator

Memorial Hermann Texas Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

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

Technical aspects of repair of juxtarenal abdominal aortic aneurysms using the Zenith fenestrated endovascular stent graft. [2016]

2. United States 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. [2019]

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

Maximizing proximal seal zone in fenestrated endografting: Evolution in the approach to graft configuration. [2021]

4. United States 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. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Superior mesenteric artery outcomes after large fenestration strut relocation with the Zenith Fenestrated endoprosthesis. [2020]

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

Institutional experience with the Zenith Fenestrated aortic stent graft. [2018]

7. United States 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. [2022]

8. United States 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. [2017]

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

Unrestricted use of endeavor resolute zotarolimus-eluting stent in daily clinical practice: a prospective registry. [2019]

10. United States 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. [2016]