Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Feb 6, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to repair complex aortic problems using specially modified devices called physician-modified endovascular grafts (PMEGs). These devices are designed for patients who have serious conditions like abdominal aortic aneurysms, thoracoabdominal aortic aneurysms, or aortic dissections, and who may not be able to undergo traditional open surgery due to health risks. The study is currently recruiting participants aged 21 and older who have specific types of aortic issues that can't be treated with standard medical devices.

If you or a loved one is considering joining this trial, you can expect to receive careful monitoring and follow-up throughout the process. Participants will be closely watched to ensure the safety and effectiveness of the PMEGs. It’s important to note that this trial is for high-risk patients, meaning those who may face serious complications if they undergo traditional surgery. Overall, this study aims to determine if these modified grafts can provide a safer and effective alternative for treating complex aortic conditions.

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• General inclusion criteria (applicable to all 3 study arms):
• • Aortic pathology that fits one of the study arms (see below for detailed description)
• • Aortic pathology that cannot be treated within the Instructions for Use of an FDA- approved, commercially-available device
• • Aortic aneurysm that can be treated within the Instructions for Use of an FDA-approved, commercially-available custom-manufactured device but deemed unsafe to wait the required time for device manufacturing
• • Subject is at high-risk of morbidity and mortality with open surgical repair based on cardiopulmonary function, extent of comorbid disease, and anatomic complexity
• • Iliac and/or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical or endovascular conduit
• * Non-aneurysmal aortic segment proximal to the aortic pathology with a:
• • Minimum neck length of 20 mm
• • Diameter between 20 - 42 mm
• * Non-aneurysmal aortic or iliac segment distal to the aortic pathology with:
• • Aortic distal fixation site greater than 20 mm in length and diameter between 20-42 mm
• • Iliac artery distal fixation site greater than 10 mm in length and diameter range 8- 25 mm
• • Age ≥21 years old
• • Life expectancy: ≥2 years
• Arm1:
• • Complex abdominal aortic aneurysm, specifically juxtarenal or suprarenal abdominal aortic aneurysm or type IV thoracoabdominal aortic aneurysm, with maximum diameter of ≥5.5 cm for men or ≥5.0 cm for women, growth ≥0.5 cm in 6 months, or concomitant iliac aneurysm ≥3 cm
• • Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair, without aneurysmal disease extending above the diaphragmatic hiatus
• • Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and/or CA for repair, without aneurysmal disease above the diaphragmatic hiatus
• • Saccular complex abdominal aortic aneurysm deemed at significant risk for rupture
• • Symptomatic complex aortic aneurysm
• • Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, without involvement of the aorta above the diaphragmatic hiatus
• • Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, without involvement of the aorta above the diaphragmatic hiatus
• Arm2:
• • Type I, II, or III thoracoabdominal aortic aneurysm with maximum diameter of ≥5.5 cm, or growth ≥0.5 cm in 6 months
• • Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair with aneurysmal disease extending above the diaphragmatic hiatus
• • Prior thoracic endovascular aneurysm repair with loss of distal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair
• • Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and/or CA for repair, with aneurysmal disease above the diaphragmatic hiatus
• • Saccular type I, II, or III thoracoabdominal aortic aneurysm deemed at significant risk for rupture
• • Symptomatic type I, II, or III thoracoabdominal aortic aneurysm
• • Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, with involvement of the aorta above the diaphragmatic hiatus
• • Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, with involvement of the aorta above the diaphragmatic hiatus
• Arm 3:
• • Acute or chronic type B aortic dissection with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or persistence of symptoms despite optimal medical therapy
• • Prior repair of type A dissection and development of acute or chronic type B dissection component with indication for repair (listed above)
• • Aortic intramural hematoma (IMH) with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or more typically, persistence of symptoms despite optimal medical therapy
• • Arm 4
• • Patient does not meet the inclusion/exclusion criteria of Arms 1 - 3
• • Patient has prohibitive operative risk for open repair and no other viable endovascular treatment option
• • Estimated perioperative risk is lower than the estimated 1-year mortality without surgery
• EXCLUSION CRITERIA:
• • General Exclusion Criteria
• • Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
• • Subject is unwilling to comply with the follow-up schedule
• • Inability or refusal to give informed consent by subject or legal representative
• • Subject is pregnant or breastfeeding
• • Subject has a ruptured aneurysm
• • Medical Exclusion Criteria
• • Known sensitivities or allergies to the materials of construction of the devices
• • Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
• • Uncorrectable coagulopathy
• • Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
• • Systemic or local infection that may increase the risk of endovascular graft infection
• • Diagnosis of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
• • Anatomic Exclusion Criteria
• • Inability to perform open or endovascular iliac conduit in patients with inadequate femoral/iliac access
• • Excessive thrombus or calcification within the neck of the aneurysm
• • Visceral vessel anatomy not compatible with placement of a physician-modified endovascular graft due to occlusive disease or small size