Endovascular Graft Repair for Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

Overseen by Javairiah Fatima, M.D

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medstar Health Research Institute

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.

Do I need to stop taking my current medications for this trial?

The trial protocol 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 idea that Endovascular Graft Repair for Aortic Aneurysm is an effective treatment?

The available research does not provide any data on Endovascular Graft Repair for Aortic Aneurysm. Instead, it focuses on treatments for brain metastases from lung cancer, such as gamma knife radiosurgery and whole-brain radiotherapy. Therefore, there is no information here to support the effectiveness of Endovascular Graft Repair for Aortic Aneurysm. ^{1 2 3 4 5}

What safety data is available for the Zenith Alpha Thoracic Endovascular Graft?

Several studies have evaluated the safety of the Zenith Alpha Thoracic Endovascular Graft. A one-year international multicenter study assessed its safety and effectiveness for treating descending thoracic aortic aneurysms and large ulcers. The TRANSFIX study provided updated safety results for treating blunt thoracic aortic injuries (BTAI) with this device. Another study reported 30-day safety outcomes for BTAI treatment. Additionally, initial clinical experiences in Europe evaluated the safety and efficacy of the low-profile version of the graft for thoracic endovascular aortic repair. ^{6 7 8 9 10}

Is the treatment Zenith Alpha Thoracic Endovascular Graft a promising treatment for aortic aneurysm?

Yes, the Zenith Alpha Thoracic Endovascular Graft is a promising treatment. Studies show it is safe and effective for repairing aortic aneurysms and injuries. It is designed to be less invasive, which can be beneficial for patients with smaller or damaged blood vessels. ^{6 7 8 9 11}

Eligibility Criteria

This trial is for adults with large aortic aneurysms who are at high risk for open surgery. Candidates must have a life expectancy over 2 years, compatible anatomy for the device, and no severe allergies to device materials. Pregnant or breastfeeding individuals, those with certain connective tissue diseases or infections, and those unable to undergo imaging tests due to body size are excluded.

Inclusion Criteria

You are expected to live for more than 2 years.

I am 18 years old or older.

My doctor thinks my aneurysm is at high risk of bursting.

Exclusion Criteria

I have not had major surgery unrelated to aneurysm treatment within the last 30 days.

I have or might have a connective tissue disorder like Marfan or Ehler's Danlos Syndrome.

I have or may have a connective tissue disease.

Treatment Details

Interventions

• Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft (Endovascular Graft)

Trial Overview The study is testing a modified Cook Alpha Thoracic Endovascular Graft in patients with complex aortic aneurysms. It aims to evaluate the safety and initial effectiveness of this custom-fit graft designed by physicians specifically for each patient's unique anatomy.

Participant Groups

Group I: Endovascular repair Experimental Treatment 1 Intervention

Endovascular repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms including those secondary to aortic dissection using a physician-modified endovascular graft.

Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Zenith Alpha Thoracic Endovascular Graft for:

• Aneurysms or ulcers of the descending thoracic aorta

🇺🇸 Approved in United States as Zenith Alpha Thoracic Endovascular Graft for:

• Isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair

🇨🇦 Approved in Canada as Zenith Alpha Thoracic Endovascular Graft for:

• Aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MedStar Washington Hospital Center Washington, United States

Who Is Running the Clinical Trial?

Medstar Health Research Institute Lead Sponsor

References

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

Surgery and radiotherapy compared with gamma knife radiosurgery in the treatment of solitary cerebral metastases of small diameter. [2006] The aim of this retrospective study was to compare treatment results of surgery plus whole-brain radiation therapy (WBRT) with gamma knife radiosurgery alone as the primary treatment for solitary cerebral metastases suitable for radiosurgical treatment.

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

Whole brain radiotherapy with a conformational external beam radiation boost for lung cancer patients with 1-3 brain metastasis: a multi institutional study. [2021] To determine the outcome of patients with brain metastasis (BM) from lung cancer treated with an external beam radiotherapy boost (RTB) after whole brain radiotherapy (WBRT).

3. Austria pubmed.ncbi.nlm.nih.gov

Efficacy and limitations of salvage gamma knife radiosurgery for brain metastases of small-cell lung cancer after whole-brain radiotherapy. [2022] The efficacy and limitations of salvage gamma knife surgery (GKS) have not been thoroughly described. This study evaluated the efficacy of GKS for treating brain metastases associated with small-cell lung cancer (SCLC) after whole-brain radiotherapy (WBRT) as the first-line radiation therapy.

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Multiple gamma knife radiosurgery for multiple metachronous brain metastases associated with lung cancer : survival time. [2021] We compared the survival time between patients with multiple gamma knife radiosurgery (GKRS) and patients with a single GKRS plus whole brain radiation therapy (WBRT), in patients with multiple metachronous brain metastases from lung cancer.

5. England pubmed.ncbi.nlm.nih.gov

Phase II clinical trial of whole-brain irradiation plus three-dimensional conformal boost with concurrent topotecan for brain metastases from lung cancer. [2022] Patients with brain metastases from lung cancer have poor prognoses and short survival time, and they are often excluded from clinical trials. Whole-cranial irradiation is considered to be the standard treatment, but its efficacy is not satisfactory. The purpose of this phase II clinical trial was to evaluate the preliminary efficacy and safety of the treatment of whole-brain irradiation plus three-dimensional conformal boost combined with concurrent topotecan for the patients with brain metastases from lung cancer.

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

One-year outcomes from the international multicenter study of the Zenith Alpha Thoracic Endovascular Graft for thoracic endovascular repair. [2018] This study evaluated the safety and effectiveness of the Zenith Alpha Thoracic Endovascular Graft (Cook Medical, Bloomington, Ind) for the treatment of descending thoracic aortic aneurysms and large ulcers.

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

Updated outcomes from the TRANSFIX study to evaluate endovascular repair of blunt thoracic aortic injuries with the Zenith Alpha thoracic device. [2020] The purpose of this study was to report the updated results of a prospective, multicenter, nonrandomized, single-arm investigational device exemption study conducted at 17 sites in the United States to assess safety and effectiveness of the Zenith Alpha thoracic endovascular graft (Cook Medical, Bloomington, Ind) for treatment of blunt thoracic aortic injury (BTAI).

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

Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device. [2015] The objective of this study was to report 30-day results from a prospective, nonrandomized, multicenter trial that evaluated the safety and effectiveness of the Zenith Alpha thoracic endovascular graft (Cook Medical, Bloomington, Ind) for treatment of blunt thoracic aortic injuries (BTAIs).

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

Initial clinical experience with a new low-profile thoracic endograft. [2015] The Zenith Alpha thoracic endograft (William Cook Europe, ApS, Bjaeverskov, Denmark) is a new low-profile thoracic endograft that has recently become commercially available in Europe. The reduced profile offers potential benefits and extended applicability, especially in patients with small or diseased iliofemoral vessels. The aim of this study was to evaluate the safety and efficacy of thoracic endovascular aortic repair performed with the new Zenith Alpha thoracic endograft.

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

Zenith abdominal aortic aneurysm endovascular graft. [2012] The safety and efficacy of the Zenith (Cook Inc, Bloomington, Ind) endovascular graft was assessed based on the United States multicenter trial through 5 years of follow-up.

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

Durability of a low-profile stent graft for thoracic endovascular aneurysm repair. [2018] The introduction of lower profile endografts expanded the application of aortic endovascular repair. However, evidence about their durability is still scarce. The objective of this study was to assess longer term durability of the Zenith Alpha Thoracic Stent Graft (Cook Inc, Bloomington, Ind) after thoracic endovascular aortic repair.