Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms

Conditions

• Freedom From Aortic Aneurysm Enlargement at 12 Months
• Freedom From Aortic Aneurysm Rupture or Conversion to Open Repair at 12 Months
• Freedom From Stent Graft Migration at 12 Months
• Freedom From Type I and III Endoleaks at 12 Months
• Technical Sucess

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Physician Modified Endografting — DEVICE
  This is the only intervention in the study

Study Details

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.

Key Dates

Start date

Jun 3, 2025

Status verified

Jun 2025

Primary completion

Jun 3, 2030

Completion

Jun 3, 2035

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Physician Modified Endograft Group
  Patients in this arm will undergo physician modified endovascular grafting of their juxtarenal aortic aneurysm

Primary Outcome Measure

Technical success [ Time Frame: Periprocedural ]

Central Contacts

• Erin Daley, MPH, BS
  413-794-8704
  [email protected]
• Hazel Marecki, MD
  413-794-0900
  [email protected]

Locations (1)

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