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New treatment option for Abdominal Aortic Aneurysms
Official title Physician-Modified Endografts for Complex Aortic Aneurysms and Thoracoabdominal Aneurysm Repair in High-Risk Patients
ClinicalTrials.gov ID: NCT07224230
What this study is testing
- What it's testing
- This single-arm FDA-monitored protocol intends to broaden endovascular device applicability using physician-modifications in patients who A) Have anatomical conditions not amenable to endovascular repair using currently marketed grafts in the United States. B) Are at high risk for open surgical repair.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient is \> 18 years of age.
- Patients who are male or non-pregnant female (females of childbearing potential must have a negative pregnancy test prior to enrollment into the...
- Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form
- The subject has at least one of the following:
- . An aortic or aortoiliac aneurysm with a maximum diameter of ≥ 5.5cm for males, ≥ 5.0cm for females
You likely can't join if
- patient has a mycotic aneurysm
- patient has a systemic or local infection that may increase the risk of graft infection.
- Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment.
- Subject has had a major surgical or treatment procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair.
- Patient is currently participating in another investigational device or drug clinical trial.
- Eligible for treatment with FDA-approved marketed device
See the full eligibility criteria
Who can join
- Patient is \> 18 years of age.
- Patients who are male or non-pregnant female (females of childbearing potential must have a negative pregnancy test prior to enrollment into the study)
- Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form
- The subject has at least one of the following:
- . An aortic or aortoiliac aneurysm with a maximum diameter of ≥ 5.5cm for males, ≥ 5.0cm for females
- Aortic Aneurysm with a history of growth ≥ 0.5 cm in 6 mos.
- Symptomatic aneurysm
- Morphology such as saccular aneurysms
- Aneurysms meeting any of the above criteria a-e above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.
- Cannot be treated with a currently available non-modified approved device.
- Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified graft or is suitable for an iliac conduit.
- Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20mm.
- Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥15mm.
- The resultant repair should preserve patency in at least one hypogastric artery.
- Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20mm.
- Chronic Dissection with aneurysmal degeneration that meets size criteria as described above for repair
- Type 1A endoleak requiring extension above the previous repair into the pararenal or paravisceral portion of the aorta to achieve 2 cm of seal.
What rules you out
- patient has a mycotic aneurysm
- patient has a systemic or local infection that may increase the risk of graft infection.
- Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment.
- Subject has had a major surgical or treatment procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair.
- Patient is currently participating in another investigational device or drug clinical trial.
- Eligible for treatment with FDA-approved marketed device
- Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturermade device at another institution.
- Unwilling to comply with the follow-up schedule.
- Inability or refusal to give informed consent by subject or legal representative. - The subject is pregnant or breastfeeding.
- Known sensitivities or allergies to the materials of construction of the devices, including stainless steel, polyester, polypropylene, nickel, titanium, or gold. - Known hypersensitivity or contraindication to...
- Uncorrectable coagulopathy
- Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
- Systemic or local infection that may increase the risk of endovascular graft infection.
- History of connective tissue disorders (e.g., Marfan Syndrome, Ehlers's Danlos Syndrome) without landing zone created from graft via previous open repair. - Patient has active malignancy with life expectancy of less...
- Patient has a limited life expectancy of less than 2 years.
- Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pretreatment, required treatment, and post-treatment procedures and evaluations.
- Anatomical exclusion criteria such as significant occlusive disease, tortuosity or calcification that would prevent endovascular access.
- proximal seal site with a circumferential thrombus/atheroma
- inability to maintain at least one hypogastric artery.
- shaggy aorta
- patient is not amenable to a temporary or permanent open surgical or endovascular conduit.
- Thrombus or excessive calcification within the neck of the aneurysm
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.