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

  • STATUS
    Recruiting
  • End date
    Dec 23, 2028
  • participants needed
    270
  • sponsor
    Darren Schneider, M.D.
Updated on 23 October 2022

Summary

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.

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 a standard configuration branched and fenestrated stent graft (TAAA Device) or physician-specified branched and fenestrated stent grafts (Physician-Specified TAAA Devices) 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 a physician-specified aortic arch stent graft device [1) double inner branch stent-graft with or without retrograde left subclavian branch 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.

Details
Condition Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm
Treatment Endovascular treatment of Thoracoabdominal Aortic Aneurysm, Endovascular treatment of Aortic Arch Aneurysms
Clinical Study IdentifierNCT02323581
SponsorDarren Schneider, M.D.
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

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
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
External iliac diameter ≥ 6mm diameter, and absence of severe calcification and tortuosity
Minimum common iliac artery luminal diameter ≥ 14mm
Cardiac disease
Patients deemed high risk for open repair (meeting one, or more, of the following
CAD (history of MI or angina with positive stress test and not revascularizable)
criteria)
LV Ejection fraction < 40%
Age ≥ 65 year
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
free from circumferential thrombus
Distal aortic landing zone
≥ 20 mm long
Native aorta or surgical graft
≤ 42 mm and ≥ 20 mm diameter in parallel aorta
free from circumferential thrombus
≥ 20 mm long
Adequate supra-aortic trunk branch landing zone(s)
≤ 42 mm and ≥ 20 mm diameter in parallel aorta
Innominate artery (if applicable)
Native vessel or surgical graft
≥ 50mm length from native coronary arteries or patent coronary bypass graft to innominate artery
Diameter: 8-22mm
Acceptable tortuosity
Absence of dissection in landing zone
Left (or right) common carotid artery (if applicable)
Length of sealing zone ≥10mm
Native vessel or surgical graft
Diameter 6-16mm
Acceptable tortuosity
Absence of dissection in landing zone
Left (or right) subclavian artery (if applicable)
Length of sealing zone ≥10mm
Native vessel or surgical graft
Diameter: 5-20mm
Acceptable tortuosity
Absence of dissection in landing zone
Iliac artery access
Length of sealing zone ≥10mm
Or, planned creation of surgical conduit for TAAA device delivery
Age > 70 years-old
≥ 6mm diameter, and absence of severe calcification and tortuosity
Prior ascending or aortic arch repair
Patients deemed high risk for open surgical aortic arch repair based upon consensus of
Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test
both a qualified cardiac surgeon and a qualified vascular surgeon and meeting
Chronic pulmonary disease with FEV1 < 1500ml
one, or more, of the following criteria)
Large aneurysm abutting the sternotomy
Severe deconditioning or immobility
Multiple (≥2) median sternotomies
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
Chronic kidney disease with eGFR ≤ 60 ml/kg/hr

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
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