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

RecruitingNAAges 18 Years - anyAllBaystate Medical Center
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In plain words

What the trial is, and whether it could suit you

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 investiga

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Patient is โ‰ฅ 18 years of age 2. 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) 3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form 4. Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following: 1. An aneurysm with a maximum diameter of โ‰ฅ 5.5 cm for male (โ‰ฅ 5.0 cm for female) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements 2. Aneurysm with a history of growth \> 0.5 cm in 6 months 3. Saccular aneurysm deemed at significant risk for rupture 4. Symptomatic aneurysm 5. Ruptured aneurysm 5. 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. 6. Patient has a suitable non-aneurysmal proximal aortic neck of โ‰ฅ 2 mm inferior to the most distal renal artery ostium. 7. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of โ‰ฅ 15mm. The resultant repair should preserve patency in at least one hypogastric artery. 8. 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. 9. Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm. 10. Patient has juxtarenal aortic neck angulation โ‰ค 60ยฐ 11. Target branch vessel diameter โ‰ฅ 5 mm. 12. Patient must be willing to comply with all required follow-up exams. Exclusion Criteria: 1. Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection 2. 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) 3. Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +/- 30 days of the AAA repair. 4. Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's- Danlos syndrome). 5. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment. 6. Patient has known allergy or intolerance to stainless steel, nitiol, or gold (gold-plated tungsten) 7. Patient has a body habitus that would inhibit X-ray visualization of the aorta 8. Patient has a limited life expectancy of less than 1 year 9. Patient is currently participating in another investigational device or drug clinical trial 10. 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. 11. Thrombus or excessive calcification within the neck of the aneurysm 12. Branch vessel stenosis โ‰ฅ 80 % 13. Patients treatable on label with FDA approved EVAR or FEVAR device and can wait for device availability. 14. Subject is willing and eligible to enroll in a manufacturer-sponsored study at the investigational site, or the subject is willing and eligible to participate in a study with a manufacturer-made device at another institution.
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What it tests

  • Physician Modified Endografting
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Where

1 site
Baystate Medical Center
Springfield, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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