Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

Official title

Feasibility, Safety, and Clinical Outcomes of Endovascular Treatment of Thoracoabdominal Aortic Aneurysms and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

Overview

Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.

Detailed description

To assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery in two study arms:

1. TAAA (thoracoabdominal aortic aneurysm) Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using either a multibranched stent graft (Off-the-Shelf TAAA Device) or custom-manufactured physician-specified branched and/or fenestrated stent graft (Physician-Specified TAAA Device) to treat aortic aneurysms involving the mesenteric and/or renal arteries (TAAA) in patients at high risk for open surgery. 2. Aortic Arch Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using 1) physician-specified aortic arch stent graft device with up to 3 antegrade and/or retrograde branches or 2) a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery\] to treat aortic aneurysms involving the aortic arch in patients at high risk for open surgery.

Interventions

• Device Endovascular treatment of Thoracoabdominal Aortic Aneurysm
  A TAAA is an abnormal enlargement (ballooning out) of the main artery (the aorta) and involves all or part of the aorta in your chest as well as all or part of the aorta in the abdomen. It also involves the part of the aorta where the arteries that bring blood to the liver, stomach and intestines and kidneys are attached. This investigational procedure that is being studied uses stent-grafts (cylindrical fabric tubes (grafts), with metal springs (stents) attached). The stent-grafts are placed i
• Device Endovascular treatment of Aortic Arch Aneurysms
  An aortic arch aneurysm is an abnormal enlargement (ballooning out) of the main artery (the aorta). The ascending aorta and aortic arch is the first part of the vessel as it exits the heart and makes a turn around the area of the collar bone. This part of the aorta gives branches that supply the head, brain and arms. The arch branch endovascular graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of

Primary outcome measures

• Technical Success [Time frame: Intraoperative]
• Procedural Success [Time frame: 30 days]
• Freedom from aneurysm-related mortality at 1 year [Time frame: 1 year]
• Treatment success at 12 months post-procedure [Time frame: 1 year]

Secondary outcome measures (12)

• Target artery patency [Time frame: Yearly through 5 years]
• Freedom from all-cause mortality [Time frame: Yearly through 5 years]
• Freedom from reintervention [Time frame: Yearly through 5 years]
• Freedom from endoleak [Time frame: Yearly through 5 years]
• Freedom from aneurysm dilatation [Time frame: Yearly through 5 years]
• Freedom from serious adverse events (SAE) and major complications [Time frame: Yearly through 5 years]
• Freedom from aneurysm rupture and conversion to open repair [Time frame: Yearly through 5 years]
• Freedom from stent graft migration and branch device migration [Time frame: Yearly through 5 years]
• Freedom from major stroke [Time frame: Yearly through 5 years]
• Freedom from paralysis [Time frame: Yearly through 5 years]
• Freedom from onset permanent hemodialysis [Time frame: Yearly through 5 years]
• Freedom from amputation [Time frame: Yearly through 5 years]

Eligibility criteria

TAAA STUDY ARM

Inclusion criteria

• Presence of TAAA in:

• Men with TAAA greater than or equal to 6 cm in diameter
• Women with TAAA greater than or equal to 5 cm in diameter
• Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
• Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or
• Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter
• Life expectancy more than 2 years
• Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol
• Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":

• Proximal aortic landing zone:

• ≥ 20mm long
• ≤ 40mm and ≥ 20mm diameter in parallel aorta
• free from circumferential thrombus
• ≤ 60 degrees angulation
• Mesenteric/renal aortic diameter ≥ 20mm
• Mesenteric arteries:

• ≥ 10mm long segment of healthy artery for branch attachment
• Diameter ≥ 4mm and ≤ 12mm
• Absence of aberrant or early branching, aneurysm or dissection
• Renal arteries:

• ≥ 10mm long segment of healthy artery for branch attachment
• Diameter ≥ 4mm and ≤ 8mm
• Absence of aberrant or early branching, aneurysm or dissection
• Iliac artery access:

• ≥ 6mm diameter, and absence of severe calcification and tortuosity
• Or, planned creation of surgical conduit for TAAA device delivery
• For patients with associated common iliac artery aneurysms (>20mm diameter), adequate internal and external iliac artery landing zones and common iliac artery luminal diameter (for iliac branch device use):

• ≥ 10mm long segment of healthy internal iliac artery for branch attachment
• Internal iliac diameter ≥ 5mm and ≤ 12mm
• External iliac diameter ≥ 6mm diameter, and absence of severe calcification and tortuosity
• Minimum common iliac artery luminal diameter ≥ 14mm
• Or, in patients with bilateral common iliac artery aneurysms without suitable anatomy, planned surgical bypass to maintain patency of at least one internal iliac artery
• Patients deemed high risk for open repair (meeting one, or more, of the following criteria):

• Age ≥ 65 year
• Cardiac disease:

• CAD (history of MI or angina with positive stress test and not revascularizable)
• LV Ejection fraction < 40%
• Symptomatic CHF (NYHC Class II, III, or IV)
• Pulmonary disease:

• Home oxygen therapy
• FEV1 < 1.2 l/s
• Vital capacity < 50% predicted
• PaCO2 > 45 mm Hg or < 60 mm Hg
• Renal disease:

• ESRD on dialysis
• eGFR < 60
• Prior aortic surgery
• Hostile abdomen
• Portal hypertension (ascites or varices)
• Coagulopathy

AORTIC ARCH STUDY ARM

Inclusion criteria

• Presence of aortic arch aneurysm in:

• Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or
• Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or
• Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
• Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
• Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation
• Life expectancy more than 2 years
• Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol.
• Suitable arterial anatomy for endovascular aortic arch repair with "Aortic Arch Device":

• Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass
• Proximal aortic landing zone:

• Native aorta or surgical graft
• ≥ 20 mm long
• ≤ 42 mm and ≥ 20 mm diameter in parallel aorta
• free from circumferential thrombus
• Distal aortic landing zone:

• Native aorta or surgical graft
• ≥ 20 mm long
• ≤ 42 mm and ≥ 20 mm diameter in parallel aorta
• free from circumferential thrombus
• ≥ 50mm length from native coronary arteries or patent coronary bypass graft to innominate artery
• Adequate supra-aortic trunk branch landing zone(s):

• Innominate artery (if applicable):

• Native vessel or surgical graft
• Diameter: 8-22mm
• Length of sealing zone ≥10mm
• Acceptable tortuosity
• Absence of dissection in landing zone
• Left (or right) common carotid artery (if applicable):

• Native vessel or surgical graft
• Diameter 6-16mm
• Length of sealing zone ≥10mm
• Acceptable tortuosity
• Absence of dissection in landing zone
• Left (or right) subclavian artery (if applicable):

• Native vessel or surgical graft
• Diameter: 5-20mm
• Length of sealing zone ≥10mm
• Acceptable tortuosity
• Absence of dissection in landing zone
• Iliac artery access:

• ≥ 6mm diameter, and absence of severe calcification and tortuosity
• Or, planned creation of surgical conduit for TAAA device delivery
• Patients deemed high risk for open surgical aortic arch repair based upon consensus of both a qualified cardiac surgeon and a qualified vascular surgeon and meeting one, or more, of the following criteria):

• Age > 70 years-old
• Prior ascending or aortic arch repair
• Multiple (≥2) median sternotomies
• Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test
• Chronic pulmonary disease with FEV1 < 1500ml
• Chronic kidney disease with eGFR ≤ 60 ml/kg/hr
• Large aneurysm abutting the sternotomy
• Severe deconditioning or immobility
• Prior cervical irradiation
• Other medical condition associated with prohibitive high risk with open repair based upon multidisciplinary consensus (cardiac surgery and vascular surgery)

APPLIES TO BOTH STUDY ARMS

Exclusion criteria

• Rupture, with hypotension (systolic bp < 90).
• Pregnancy or breastfeeding.
• Unwillingness or inability to comply with the follow up schedule.
• Serious systemic or groin infection.
• Uncorrectable coagulopathy.
• Age < 18 years.
• Mycotic aneurysm.
• Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).
• Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold.
• Participation in another in another investigational device or drug study within 1 year of treatment.
• Unrelated concomitant major surgical or interventional procedure(s) within 30 days of treatment date (with the exception of staged procedures planned as part of treatment)
• Body habitus that would inhibit X-ray visualization of the aorta.
• Acute aortic dissection
• Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• New York Presbyterian Hospital — New York
• Hospital of the University of Pennsylvania — Philadelphia

Publications

• Meltzer AJ, Connolly PH, Ellozy S, Schneider DB. Patient-reported Quality of Life after Endovascular Repair of Thoracoabdominal Aortic Aneurysms. Ann Vasc Surg. 2017 Oct;44:164-170. doi: 10.1016/j.avsg.2017.04.009. Epub 2017 May 17. PMID 28527678
• Stern JR, Ellozy SH, Connolly PH, Meltzer AJ, Schneider DB. Utility and safety of axillary conduits during endovascular repair of thoracoabdominal aneurysms. J Vasc Surg. 2017 Sep;66(3):705-710. doi: 10.1016/j.jvs.2016.12.107. Epub 2017 Mar 1. PMID 28259569
• Schneider DB, Agrusa CJ, Ellozy SH, Connolly PH, Meltzer AJ, Graham AR, Michelassi F. Analysis of the Learning Curve and Patient Outcomes of Endovascular Repair of Thoracoabdominal Aortic Aneurysms Using Fenestrated and Branched Stent Grafts: Prospective, Nonrandomized, Single-center Physician-sponsored Investigational Device Exemption Clinical Study. Ann Surg. 2018 Oct;268(4):640-649. doi: 10.109 PMID 30080733
• Dias-Neto M, Vacirca A, Huang Y, Baghbani-Oskouei A, Jakimowicz T, Mendes BC, Kolbel T, Sobocinski J, Bertoglio L, Mees B, Gargiulo M, Dias N, Schanzer A, Gasper W, Beck AW, Farber MA, Mani K, Timaran C, Schneider DB, Pedro LM, Tsilimparis N, Haulon S, Sweet MP, Ferreira E, Eagleton M, Yeung KK, Khashram M, Jama K, Panuccio G, Rohlffs F, Mesnard T, Chiesa R, Kahlberg A, Schurink GW, Lemmens C, Gal PMID 37395613
• Finnesgard EJ, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Simons JP, Schanzer A; United States Aortic Research Consortium. Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair. J Vasc Surg. 2023 Oct;78(4):892-901. doi: 10.1016/j.jvs.2023.05.034. Epub 2023 Jun PMID 37330702
• Abdelhalim MA, Tenorio ER, Oderich GS, Haulon S, Warren G, Adam D, Claridge M, Butt T, Abisi S, Dias NV, Kolbel T, Gallitto E, Gargiulo M, Gkoutzios P, Panuccio G, Kuzniar M, Mani K, Mees BM, Schurink GW, Sonesson B, Spath P, Wanhainen A, Schanzer A, Beck AW, Schneider DB, Timaran CH, Eagleton M, Farber MA, Modarai B; Multicenter International Aortic Research Group. Multicenter trans-Atlantic expe PMID 37321524
• Aucoin VJ, Motyl CM, Novak Z, Eagleton MJ, Farber MA, Gasper W, Oderich GS, Mendes B, Schanzer A, Tenorio E, Timaran CH, Schneider DB, Sweet MP, Zettervall SL, Beck AW; U.S. Aortic Research Consortium. Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium. J Vasc Surg. 2023 Jun;77(6):1578-1587. doi: 10.1 PMID 37059239
• Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Huang Y, Oderich GS; U.S. Fenestrated and Branched Aortic Research Consortium. Mid-term Renal and Mesenteric Artery Outcomes During Fenestrated and Branched Endovascular Aortic Repair for Complex Abdominal and Thoracoabdominal Aortic Aneurysms in the United States Aortic Re PMID 37051912

Identifiers

NCT: NCT02323581 · 843522

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗