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| ID | Type | Description | Link |
|---|---|---|---|
| G240287 | Other Identifier | FDA |
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Patients who are found to have an aneurysm (bulge) in the abdominal aorta, which is the blood vessel in your abdomen (belly) that supplies blood to most of your lower body, including major organs and your legs. As an aneurysm expands, the walls of the aorta become weak and may rupture (break open), causing a major loss of blood with a high risk of serious problems and death. To avoid this risk, doctors repair aneurysms by either open surgery (incision) or endovascular surgery (covered stents to channel the blood flow). Juxtarenal aneurysms (those that come close to the kidney arteries) present a unique challenge as they are more dangerous to repair by open therapy and do not fit the standard approved endovascular devices. The purpose of this study is to assess the effects of the physician-modified endovascular graft (PMEG) by collecting information about the performance of this investigational medical device.
The main graft looks like a pair of pants with very short legs. The top of the pants is placed in the aorta. Then, two smaller grafts go from the main graft and to your iliac arteries (the main arteries supplying blood to your abdomen and legs) to form the legs of the pair of pants. Each graft is packed into a small catheter (a long, flexible plastic tube) that is placed into your aorta through the femoral artery in your groin (top of your leg). The grafts are then placed in the correct position in your aorta by releasing them from the catheters. These grafts are investigational because the research physician has changed them to match patient anatomy (body make up) while protecting blood flow to important vessels. Once the grafts are attached inside the aorta, they will support the area of the aorta that is weakened and bulging.
Modifications of the graft will include between one and four holes (fenestrations) near the top of the graft. The holes allow the graft to be located above the renal arteries (the blood vessels that supply blood to your kidneys) without blocking the blood flow to them. One or more of the arteries will also be treated with a stent (metal wire tube) to help keep the arteries open and to keep the arteries connected to the holes that are made for the graft.
The device is custom modified for patient specific anatomy. The information collected from this study will be used to show how well patients do when treated with the modified graft, both immediately after surgery and over a long period of time. After the procedure, labs, CT imaging with contrast, XRays and ultrasounds will be done to check the graft at intervals 1 month, 6 months, 12 months and yearly for 5 years. These are standard surveillance studies performed on any endovascular aneurysm repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physician Modified Endograft Group | Experimental | Patients in this arm will undergo physician modified endovascular grafting of their juxtarenal aortic aneurysm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physician Modified Endografting | Device | This is the only intervention in the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | The physician was able to insert the delivery catheter and deliver the physician modified endovascular graft to the treatment site and preserve blood flow into the vessels intended to have blood flow preserved. | Periprocedural |
| Freedom from Type I and III Endoleaks at 12 months | Yes/No Type I or Type III Endoleak visualized on 12 month CT Angiography | 12 months post-procedure |
| Freedom from stent graft migration at 12 months | Yes/No stent migration at 12 months | 12 months |
| Freedom from aortic aneurysm enlargement at 12 months | Yes/No Freedom from enlargement maximal aortic diameter | 12 months |
| Freedom from aortic aneurysm rupture and conversion to open repair through 12 months | Yes/No freedom from | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Yes/No | 30 days, 6 months, 12 months, and annually through 5 years |
| Aneurysm related mortality | Yes/ No | 30 days, 6 months, 12 months, and annually through 5 years |
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Inclusion Criteria:
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 or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:
Patient has patent iliac or femoral arteries, with or without the use of conduit, that will allow endovascular access with the physician modified endovascular graft.
Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.
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 a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32 mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.
Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
Patient has juxtarenal aortic neck angulation ≤ 60°
Target branch vessel diameter ≥ 5 mm.
Patient must be willing to comply with all required follow-up exams.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Daley, MPH, BS | Contact | 413-794-8704 | erin.daley2@baystatehealth.org | |
| Hazel Marecki, MD | Contact | 413-794-0900 | hazel.marecki@baystatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Hazel Marecki, MD | Baystate Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baystate Medical Center | Recruiting | Springfield | Massachusetts | 01199 | United States |
Unidentified data may be analyzed retrospectively with other hospitals who are conducting this study for data analysis and publication of results.
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Selected patients based on anatomic criteria will be offered to be included in the study and undergo repair with physician modified endografting only if they are deemed not to be a candidate for an alternative FDA approved endovascular aortic repair device.
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| Aneurysm Rupture | Yes/ No | 30 days, 6 months, 12 months, and annually through 5 years |
| Major Adverse Events | 30 days, 6 months, 12 months, and annually through 5 years |
| Renal failure with or without permanent dialysis | Yes/No, with or without dialysis | 30 days, 6 months, 12 months, and annually through 5 years |
| Graft Infection | Yes/ No | 30 days, 6 months, 12 months, and annually through 5 years |