Endovascular repair for complex aortic conditions using modified grafts

Single-Center Investigational Device Exemption Trial: Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)

This study is testing a new type of graft to see if it can safely and effectively repair complex aortic problems in high-risk patients who can't have traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04746677 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for repairing complex aortic pathologies in high-risk patients. It is divided into three arms based on the type of aortic condition: complex abdominal aortic aneurysm, thoracoabdominal aortic aneurysm, and aortic dissection. The study aims to provide an alternative to traditional open surgical repair, which carries high risks for patients with significant comorbidities. By utilizing advanced endovascular techniques, the study seeks to improve outcomes for patients who are not eligible for existing FDA-approved devices.

Who should consider this trial

Good fit: Ideal candidates include patients with complex aortic pathologies who are at high risk for open surgical repair due to their medical conditions.

Not a fit: Patients with aortic conditions that can be treated with existing FDA-approved devices or those who are not considered high-risk for open surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a safer and more effective treatment option for patients with complex aortic conditions.

How similar studies have performed: While the use of physician-modified grafts is a novel approach, similar endovascular techniques have shown promise in treating complex aortic conditions.

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

Arm 5 • Patient meets criteria for Arms 1-4

\- Patient is undergoing repair using the TREO bifurcated stent graft

Indications for using TREO bifurcated stent graft:

* Patient has undergone a prior endovascular aortic repair and meets criteria for repair; OR
* -Patient has measured length from the lowest renal artery to the aortic bifurcation (either de novo or from a prior endograft) \< 115 mm; OR

  * In patients with notable vessel tortuosity, where centerline measurement may not accurately reflect the distance covered needed in situ; OR
  * Additional clinical or anatomic scenarios where forthcoming experience may demonstrate the TREO endograft to be superior to the currently-used Alpha/Alpha 2 endograft.

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

Where this trial is running

Boston, Massachusetts

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Jessica Kelliher, BSN

Conditions Abdominal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm; Aortic Dissection; Fenestrated endovascular aortic repair; Branched endovascular aortic repair; Complex aortic aneurysm repair