Endovascular Graft + Bridging Stent for Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

+30 other locations

Overseen by Gustavo Oderich, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Cook Research Incorporated

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

No Placebo Group

Approved in 2 Jurisdictions

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}

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

Trial 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 (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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UC San Diego La Jolla, CA

Emory University Hospital Atlanta, GA

Columbia University Irving Medical Center/NY Presbyterian Hospital New York, NY

University of Pittsburgh Medical Center Pittsburgh, PA

More Trial Locations

Who Is Running the Clinical Trial?

Cook Research Incorporated Lead Sponsor

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] Fenestrated endovascular aortic repair has been used with increasing frequency to treat complex aortic aneurysms. The Zenith fenestrated stent graft system (Cook Medical Inc, Brisbane, Queensland, Australia) was approved for commercial use in the United States in April 2012, offering a custom-made design with up to three fenestrations to treat short-neck infrarenal and juxtarenal abdominal aortic aneurysms. This report and the Video presentation (online only) summarize the preoperative planning, stent graft design, and technique of implantation of a Zenith fenestrated stent graft using a totally percutaneous approach in an 80-year-old female patient with a 6-cm juxtarenal abdominal aortic aneurysm. The patient was dismissed home the next day without complications, and a computed tomography angiography at 12 months showed no endoleak or stent graft complications.

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] Fenestrated endografts are customized, patient-specific, endovascular devices with potential to significantly reduce morbidity and mortality of short-neck infrarenal and juxtarenal abdominal aortic aneurysm repair. The Zenith fenestrated endovascular graft (ZFEN) for abdominal aortic aneurysms (Cook Medical, Bloomington, Ind), Food and Drug Administration-approved in 2012, remains the only fenestrated device available in the United States. This technology is among the most technically complex catheter-based procedures and, therefore, inherently associated with serious risk for device-related complications. We sought to define patterns of physician and hospital adoption of ZFEN.

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

Maximizing proximal seal zone in fenestrated endografting: Evolution in the approach to graft configuration. [2021] Fenestrated endografting for juxtarenal and pararenal abdominal aortic aneurysms affords the ability to seal stent grafts in normal aorta at and above the renal arteries. The Zenith fenestrated graft (ZFEN; Cook Medical, Bloomington, Ind) is custom-made to surgeon specifications, subject to certain manufacturing limitations. The most common configuration in the pivotal trial and in commercial use after approval has been as a scallop for the superior mesenteric artery (SMA) and two small fenestrations for the renal arteries (configuration A). An alternative configuration to maximize the seal zone length, consisting of a large fenestration for the SMA and two small fenestrations for the renal arteries (configuration B) has been routinely adopted at our institutions to potentially prevent type IA endoleak.

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] The Zenith Fenestrated Endovascular Graft (ZFEN; Cook Medical, Bloomington, Ind) has expanded the anatomic eligibility of endovascular aneurysm repair (EVAR) for complex abdominal aortic aneurysms (AAAs). Current data on ZFEN mainly consist of single-institution experiences and show conflicting results. Therefore, we compared perioperative outcomes after repair using ZFEN with open complex AAA repair and infrarenal EVAR in a nationwide multicenter registry.

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

Superior mesenteric artery outcomes after large fenestration strut relocation with the Zenith Fenestrated endoprosthesis. [2020] The Zenith® Fenestrated (ZFen) stent-graft is frequently configured with a strut-spanning large fenestration for superior mesenteric artery (SMA) incorporation. This has led some to relocate struts to create a strut-free fenestration and place a bridging stent. The aim of this study was to compare SMA outcomes with and without large fenestration strut relocation.

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

Institutional experience with the Zenith Fenestrated aortic stent graft. [2018] The Zenith Fenestrated (ZFEN; Cook Medical, Bloomington, Ind) aortic stent graft system was approved for commercial use by the Food and Drug Administration in April 2012. We report our single-center experience of 100 consecutive patients treated with the ZFEN platform from October 2012 to March 2017.

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] The Cobra PzF coronary stent is cobalt chromium with flat thin struts, nano-coated with Polyzene-F that enhance rapid reendothelialization and reduce the risk of stent thrombosis and restenosis. It is designed to overcome shortfalls of BMS and DES in patients requiring short DAPT duration.

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] Because of anticipated antiplatelet medication risks, patients who are not DES candidates or who are at particularly high risk for bleeding events have been targeted initially for treatment with the COBRA PzF Coronary Stent System. We report the case of a successful experience with a new, Polyzene™-F COBRA PzF™ Coronary Stent System, designed to impart thrombo-resistance and reduce inflammation, to achieve shorter dual antiplatelet therapy duration while reducing restenosis incidence in a high risk patient with atrial fibrillation.

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

Unrestricted use of endeavor resolute zotarolimus-eluting stent in daily clinical practice: a prospective registry. [2019] To evaluate the safety and efficacy of unrestricted Endeavor Resolute zotarolimus-eluting stent (ZES) use. Furthermore, we sought to evaluate clinical outcomes associated with on- and off-label use of Resolute ZES.

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] Using optical coherence tomography, we assessed the proportion of uncovered struts at 6-month follow-up in zotarolimus-eluting stents (ZES), specifically Endeavor (Medtronic CardioVascular, Santa Rosa, California) stents, and identical bare-metal stents (BMS) implanted in patients with ST-segment elevation myocardial infarction (STEMI).