Endovascular Graft Repair for Aortic Aneurysm

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing a special endovascular graft, a tiny tube used to repair complex aortic aneurysms (bulges in the main artery that can burst). The study aims to determine if this doctor-modified graft is safe and effective for patients at high risk from open surgery. It also examines the treatment's impact on kidney function, radiation exposure, and overall quality of life. This trial may suit individuals with large, rapidly growing, or symptomatic aortic aneurysms who are high-risk for traditional surgery. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance treatment options for complex aortic aneurysms.

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 prior data suggests that this device is safe for endovascular repair?

Research shows that the Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft treats complex aortic aneurysms, which are bulges in the wall of a blood vessel. In past studies, these grafts have been used successfully and safely in many patients. Most patients handle the procedure well, experiencing no severe side effects.

One study found the graft effective in treating aneurysms, with few major complications. Another study showed positive results after one year, suggesting the treatment is generally safe over time. While some minor side effects can occur, serious problems are rare.

These studies provide evidence that the treatment is well-tolerated. However, anyone interested in joining the trial should consult their doctor about the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft is unique because it targets complex aortic aneurysms and thoracoabdominal aortic aneurysms, which can be particularly challenging to treat. Unlike traditional open surgery, which requires a large incision and can lead to longer recovery times, this endovascular approach is minimally invasive. Researchers are excited because this method offers the potential for a safer, quicker recovery by reducing surgical trauma and hospital stay. Additionally, the physician-modified aspect allows for customization to better fit the patient's unique anatomy, potentially improving outcomes.

What evidence suggests that this endovascular graft is effective for aortic aneurysm repair?

Research shows that the physician-modified Cook Zenith Alpha Thoracic Endovascular Graft, which participants in this trial will receive, may help treat complex aortic aneurysms. Studies have found these modified grafts effectively manage difficult cases of abdominal and thoracoabdominal aortic aneurysms. The graft fits the aorta precisely, stabilizing the aneurysm and preventing it from bursting. Early results suggest this method can improve patient outcomes by lowering the risks associated with open surgery. Overall, the device offers a promising, less invasive option for high-risk patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Javairiah Fatima, M.D

Principal Investigator

Medstar Health Research Institute

Are You a Good Fit for This Trial?

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.

My blood vessels in the hip or thigh area are suitable for medical procedures.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04526938

Physician-modified Endovascular Graft for Repair of ... 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 ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.068587

Multicenter Study on Physician-Modified Endografts for ... Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468428725002990

Utilization of Zenith Alpha Thoracic 2.0 to Facilitate ... The updated Zenith Alpha Thoracic 2.0 (ZTA2) stent graft enables the creation of a triple retrograde inner-branched PMEG for total endovascular ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02989948

Physician-Modified Fenestrated and Branched Aortic ... This study is a prospective, two-arm, traditional feasibility study of a physician modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft base ...

5. clinicaltrial.be clinicaltrial.be/en/details/72292?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Physician-Modified Fenestrated and Branched Aortic ... This study is a prospective, two-arm, traditional feasibility study of a physician modified fenestrated Cook Zenith Alpha Thoracic ...

6. clinicaltrial.be clinicaltrial.be/fr/details/72292?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Physician-Modified Fenestrated and Branched Aortic ... This study is a prospective, two-arm, traditional feasibility study of a physician modified fenestrated Cook Zenith Alpha Thoracic ...

7. jvascsurg.org jvascsurg.org/article/S0741-5214(15)01085-X/fulltext

One-year outcomes from the international multicenter ... This study evaluated the safety and effectiveness of the Zenith Alpha Thoracic Endovascular Graft (Cook Medical, Bloomington, Ind) for the treatment of ...