BridgeMD
New treatment option for Complex Abdominal Aortic Aneurysm
Official title Physician Modified Endograft For Complex Aortic Aneurysm Repair
ClinicalTrials.gov ID: NCT05339061
What this study is testing
- What it's testing
- The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled.
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 child bearing 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
- Patient has a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysm (Extent I-V) that meets at least one of the following:
You likely can't join if
- --- -General Exclusion Criteria-
- Patient has a mycotic aneurysm
- Patient has a ruptured aneurysm requiring urgent or emergent repair
- Patient has a systemic or local infection that may increase the risk of graft infection
- Patient has a body habitus that would inhibit X-ray visualization of the aorta.
- Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution
See the full eligibility criteria
Who can join
- ------
- Patient is \> 18 years of age
- Patients who are male or non-pregnant female (females of child bearing 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
- Patient has a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysm (Extent I-V) that meets at least one of the following:
- Aortic aneurysm with diameter ≥ 5.5cm
- Aortic aneurysm with a history of growth ≥0.5cm in the last 6 months
- Symptomatic aortic aneurysm
- Cannot be treated with a currently available non-modified approved device
- High risk for open surgical repair based on any of the factors below:
- Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery
- Physiologic i. ASA Category III or higher ii. Age \>70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v...
- Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft or is suitable for an iliac conduit
- Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20 mm
- Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm.
- The resultant repair should preserve patency in at least one hypogastric artery.
- Patient has a suitable non-aneurysmal proximal aortic neck diameter between 15 and 42mm
- Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm. ---
What rules you out
- --- -General Exclusion Criteria-
- Patient has a mycotic aneurysm
- Patient has a ruptured aneurysm requiring urgent or emergent repair
- Patient has a systemic or local infection that may increase the risk of graft infection
- Patient has a body habitus that would inhibit X-ray visualization of the aorta.
- Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution
- Patient has a major surgical or treatment procedure planned within +/- 30 days of the (T)AAA repair.
- Patient is currently participating in another investigational device or drug clinical trial. -Medical Exclusion Criteria-
- Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
- Patient has a known allergy or intolerance to stainless steel, polyester, polypropylene, nickel, titanium or gold.
- Patient has uncorrectable coagulopathy
- Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
- Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
- Patient has active malignancy with life expectancy of less than 2 years
- 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 pre-treatment, required treatment, and post-treatment procedures and evaluations...
- 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 patent hypogastric artery
- Shaggy aorta
- Patient is not amenable to a temporary or permanent open surgical or endovascular conduit
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, 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 San Diego, California, 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.