Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Thoracic, Aortic Dissection, Thoracoabdominal
About this trial
This is an interventional treatment trial for Aortic Aneurysm, Thoracoabdominal focused on measuring Thoracoabdominal, Aneurysm, Endovascular, Stent-Graft, Aortic Arch, BEVAR, FEVAR, Aorta, Aortic Dissection
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 or ruptured 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
Sites / Locations
- New York Presbyterian Hospital
- Hospital of the University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
TAAA (thoracoabdominal aortic aneurysm) Study Arm
Aortic Arch Study Arm
Either the Off-the-Shelf TAAA device or the Physician-Specified TAAA Device will be implanted. The Off-the-Shelf TAAA Device is a standard configuration Zenith t-Branch with four branches for the mesenteric arteries and the renal arteries. The Physician-Specified TAAA Devices may include a combination of up to 5 fenestrations and branches for mesenteric and renal arteries. Branches will be used for downward-oriented mesenteric and renal arteries and fenestrations for renal arteries that project laterally or upwards.
Physician-specified double inner branch stent-graft with or without retrograde left subclavian branch or a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery.