RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.

Official Title

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

Quick Facts

Study Start:2021-03-15

Study Completion:2030-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04746677

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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 * 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 * 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 * 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	* 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 * 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) * 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

Inclusion Criteria

Exclusion Criteria

* 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
* 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
* 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
* 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
* 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

* 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
* 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)
* 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

Contacts and Locations

Study Contact

Theresa Bishop, BSN

CONTACT

617-632-9975

tbishop@bidmc.harvard.edu

Mary Trovato

CONTACT

617-632-7488

mtrovato@bidmc.harvard.edu

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-15

Study Completion Date2030-12-31

Study Record Updates

Study Start Date2021-03-15

Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

Fenestrated endovascular aortic repair
Branched endovascular aortic repair
Complex aortic aneurysm repair

Additional Relevant MeSH Terms

Abdominal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm
Aortic Dissection