Endovascular Graft Repair for Aortic Aneurysm

Overseen By Jake Sutton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Pregnancy, Infection, Connective tissue disorders, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: 1-2 weeks

200 Participants Needed

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.

Do I need to stop my current medications for the 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 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 Zenith Alpha Thoracic Endovascular Graft safe for humans?

The Zenith Alpha Thoracic Endovascular Graft has been studied for safety in treating conditions like thoracic aortic aneurysms and blunt thoracic aortic injuries. These studies generally support its safety in humans, with evaluations conducted at multiple centers and showing positive outcomes. ^{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}

How is the Zenith Alpha Thoracic Endovascular Graft treatment different from other treatments for aortic aneurysm?

The Zenith Alpha Thoracic Endovascular Graft is unique because it is a low-profile device, meaning it is smaller and more flexible, which makes it suitable for patients with smaller or diseased blood vessels. This design allows for a less invasive procedure compared to traditional surgical methods, potentially reducing recovery time and complications. ^{6 7 8 9 11}

Research Team

Javairiah Fatima, M.D

Principal Investigator

Medstar Washington Hospital Center

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endovascular repair of complex aortic aneurysms using a physician-modified endovascular graft

1-2 weeks

1 visit (in-person)

Follow-up

Participants undergo periodic follow-up evaluations involving physical exams, CTA, abdominal duplex ultrasound, creatinine measurement, and quality of life questionnaire

5 years

Regular visits at 30 days, 6 months, 1, 2, 3, 4, and 5 years

Treatment Details

Interventions

• Physician-Modified Cook Zenith Alpha Thoracic 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

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Findings from Research

In a study comparing 108 patients with solitary cerebral metastases, gamma knife radiosurgery alone achieved local tumor control rates comparable to surgery plus whole-brain radiation therapy (WBRT), with rates of 83% and 75% respectively.

The 1-year survival rate was slightly higher in the surgical group (53%) compared to the radiosurgery group (43%), but the difference was not statistically significant, suggesting that radiosurgery can be an effective standalone treatment for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgery and radiotherapy compared with gamma knife radiosurgery in the treatment of solitary cerebral metastases of small diameter. Muacevic, A., Kreth, FW., Horstmann, GA., et al.[2006]

In a study of 53 lung cancer patients with brain metastasis treated with whole brain radiotherapy (WBRT) followed by an external beam radiotherapy boost (RTB), the median overall survival was 14.5 months, indicating that this treatment approach can be effective for certain patients.

The study found that younger patients (under 65 years) with a good performance status and no extracranial metastasis had improved survival outcomes, suggesting that they may benefit from higher radiation doses after WBRT.

NCBI (Pubmed)

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. Casanova, N., Mazouni, Z., Bieri, S., et al.[2021]

Gamma knife surgery (GKS) is highly effective for controlling brain metastases from small-cell lung cancer (SCLC) after whole-brain radiotherapy (WBRT), achieving a tumor control rate of 95.8% in a study of 44 patients with a median follow-up of 4 months.

Patients treated with GKS had a median overall survival of 16.9 months from the diagnosis of brain metastases, with better outcomes for those with fewer than 5 metastases and without carcinomatous meningitis.

NCBI (Pubmed)

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. Nakazaki, K., Higuchi, Y., Nagano, O., et al.[2022]

Patients with multiple gamma knife radiosurgery (GKRS) had a median survival time of 18 months, significantly longer than the 6 months observed in patients receiving a single GKRS plus whole brain radiation therapy (WBRT), indicating that multiple GKRS may be more effective for extending survival in lung cancer patients with multiple brain metastases.

The study found that the average volume of individual lesions negatively impacted survival, but the number of lesions and the frequency of new lesions did not hinder the effectiveness of GKRS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple gamma knife radiosurgery for multiple metachronous brain metastases associated with lung cancer : survival time. Kim, HS., Koh, EJ., Choi, HY.[2021]

In a phase II clinical trial involving 76 patients with brain metastases from lung cancer, the combination of whole-brain irradiation, a 3-D conformal boost, and concurrent topotecan chemotherapy significantly improved progression-free survival (PFS) and intracranial lesion control rates compared to radiotherapy alone.

The median PFS for the combined treatment group was 6 months with a 1-year PFS rate of 42.8%, while the radiotherapy-only group had a median PFS of 3 months and a 1-year PFS rate of 11.6%, indicating a notable efficacy of the combined approach without a significant increase in side effects.

NCBI (Pubmed)

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. Ge, XH., Lin, Q., Ren, XC., et al.[2022]

The Zenith Alpha Thoracic Endovascular Graft was successfully implanted in 108 out of 110 patients with no 30-day mortality, indicating a high safety profile for treating descending thoracic aortic aneurysms and ulcers.

At one year, the graft showed a 95% freedom from all-cause mortality and a 99% freedom from aneurysm-related mortality, suggesting its effectiveness in managing these conditions with minimal serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcomes from the international multicenter study of the Zenith Alpha Thoracic Endovascular Graft for thoracic endovascular repair. Illig, KA., Ohki, T., Hughes, GC., et al.[2018]

In a study involving 50 patients with blunt thoracic aortic injury, the Zenith Alpha thoracic endovascular graft demonstrated a low 30-day mortality rate of 2%, with a high rate of aortic injury healing at 96% after 2 years.

Despite the overall safety and effectiveness, the study found thrombus formation in 30% of patients, leading to the manufacturer's decision to remove the device's indication for this specific injury, highlighting the need for careful device sizing and lifelong follow-up.

NCBI (Pubmed)

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. Starnes, BW., Dwivedi, A., Giglia, J., et al.[2020]

The Zenith Alpha thoracic endovascular graft demonstrated a 100% technical success rate and a low 30-day mortality rate of 2% in a study involving 50 patients with blunt thoracic aortic injuries, indicating its safety and effectiveness.

The device allows for complete percutaneous repair in 44% of patients and accommodates smaller graft sizes, making it suitable for a wider range of patients with varying aortic anatomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device. Starnes, BW., Dwivedi, AJ., Giglia, JS., et al.[2015]

The Zenith Alpha thoracic endograft was safely and effectively deployed in 42 patients with various thoracic aortic conditions, showing no major complications or perioperative mortality, even in patients with small or diseased access vessels.

At 30 days post-procedure, there were no device-related complications, and imaging confirmed 100% clinical success in excluding aneurysms and other conditions treated, indicating promising initial efficacy of this new endograft.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial clinical experience with a new low-profile thoracic endograft. Melissano, G., Tshomba, Y., Rinaldi, E., et al.[2015]

The Zenith endovascular graft demonstrated long-term safety and efficacy over a 5-year follow-up period, with low rates of aneurysm-related death (2% for standard-risk and 4% for high-risk patients) and a 100% freedom from rupture in both risk groups.

Complications such as migration, limb occlusion, and device integrity issues were rare (less than or equal to 3%), but the incidence of late endoleaks (12% to 15%) highlights the importance of ongoing monitoring for patients with endovascular grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zenith abdominal aortic aneurysm endovascular graft. Greenberg, RK., Chuter, TA., Cambria, RP., et al.[2012]

In a study of 70 patients treated with the Zenith Alpha Thoracic Stent Graft for thoracic aortic aneurysms, the ongoing clinical success rate was 87.1% over an average follow-up of 22.3 months, indicating good long-term durability.

The incidence of serious complications was low, with only 4.3% experiencing type IA endoleaks and no cases of stent fracture, suggesting that the stent graft is a safe option for endovascular aortic repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability of a low-profile stent graft for thoracic endovascular aneurysm repair. Torsello, GF., Inchingolo, M., Austermann, M., et al.[2018]

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]

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]

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]

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

Multiple gamma knife radiosurgery for multiple metachronous brain metastases associated with lung cancer : survival time. [2021]

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]

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]

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]

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

Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device. [2015]

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

Initial clinical experience with a new low-profile thoracic endograft. [2015]

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

Zenith abdominal aortic aneurysm endovascular graft. [2012]

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

Durability of a low-profile stent graft for thoracic endovascular aneurysm repair. [2018]