STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft

Study Overview
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Brief Summary
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The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA [Thoracic Aortic Aneurysm] Endovascular Graft) is a clinical trial approved by the United States Food and Drug Administration (FDA) to study the safety and effectiveness of the Zenith TX2 TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers.

Detailed Description
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The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA Endovascular Graft) is a clinical trial approved by the FDA to study the safety and effectiveness of the Zenith TX2(R) TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers. Instead of making a large incision in the chest, the physician makes a small incision near the groin to insert and guide the graft into place in the aorta, relieving pressure on the aneurysm and helping to reduce the risk of rupture. The Zenith TX2 TAA Endovascular Graft is a reinforced fabric tube that is sized to the length of the aorta that needs to be covered to seal off the aneurysm / ulcer. The graft is made of a polyester material like that used in open surgical repair. Standard surgical suture is used to sew the graft material to a frame of self-expanding stainless steel stents, which provide support. The materials used in the Zenith TX2 system have a long history of use in medical implants.

Official Title
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Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft

Conditions
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Thoracic Aortic Aneurysm

Intervention / Treatment
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* Device: Endovascular repair
* Procedure: Surgical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with aneurysms / ulcers of the descending thoracic aorta Patients who are candidates for either surgery or endovascular repair Patients at least 18 years old Exclusion Criteria: Age < 18 years Patients with other medical condition (e.g., cancer, congestive heart failure) that may cause non-compliance with the protocol, confound the results, or with limited life expectancy (i.e., less than 2 years) Patients pregnant, breast-feeding, or planning on becoming pregnant within 24 months Patients unwilling or unable to comply with the follow-up schedule Patients unable or who refuse to give informed consent Patients simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Endovascular Repair | Device: Endovascular repair<br>* Endovascular repair.<br>* Other names: TEVAR;|
| Other: 2<br>Surgical | Procedure: Surgical<br>* Surgical endovascular repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary hypothesis for effectiveness is that patients treated with the Zenith TX2(R) TAA Endovascular Graft will have equivalent 30-day rupture-free survival compared to the surgical control. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary hypothesis is subjects treated with the Zenith TX2(R) TAA Endovascular Graft will have equivalent or fewer complications compared to the surgical control group through 30 days following implant. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic Aortic Aneurysm, Descending, minimally invasive, endovascular, rupture, back pain, stent graft, endovascular aneurysm repair, aortic aneurysm, thoracic