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

Sponsor

Darren Schneider, M.D. (Other)

Overall Status

Recruiting

CT.gov ID

NCT02323581

Collaborator

(none)

270

Enrollment

Locations

Arms

181

Anticipated Duration (Months)

135

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thoracoabdominal Aortic Aneurysm Aortic Arch Aneurysm	Device: Endovascular treatment of Thoracoabdominal Aortic Aneurysm Device: Endovascular treatment of Aortic Arch Aneurysms	N/A

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:

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.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

270 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAAA (thoracoabdominal aortic aneurysm) Study Arm Either the TAAA device or the Physician-Specified TAAA Device will be implanted. The TAAA Device is a standard configuration branched stent graft with a combination of two branches for the mesenteric arteries and two fenestrations for the renal arteries. The Physician-Specified TAAA Devices are designed on a per patient basis and may include a combination of up to 4 fenestrations and branches for mesenteric and renal arteries. An additional 5th branch or fenestration may be included if there is a large accessory renal artery. Branches will be used for downward-oriented mesenteric and renal arteries and fenestrations for renal arteries that project laterally or upwards.	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 inside the aneurysmal (weakened) area of the aorta to re-line it. These customized stent-grafts have special branches attached to them or openings (called "fenestrations") that are used to keep blood flowing to the arteries that supply the liver, stomach, intestines and kidneys. The investigational stent graft will be designed and custom-made specifically for your aneurysm.
Experimental: Aortic Arch Study Arm 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.	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 cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively.

Arm

Intervention/Treatment

Experimental: TAAA (thoracoabdominal aortic aneurysm) Study Arm

Either the TAAA device or the Physician-Specified TAAA Device will be implanted. The TAAA Device is a standard configuration branched stent graft with a combination of two branches for the mesenteric arteries and two fenestrations for the renal arteries. The Physician-Specified TAAA Devices are designed on a per patient basis and may include a combination of up to 4 fenestrations and branches for mesenteric and renal arteries. An additional 5th branch or fenestration may be included if there is a large accessory renal artery. Branches will be used for downward-oriented mesenteric and renal arteries and fenestrations for renal arteries that project laterally or upwards.

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 inside the aneurysmal (weakened) area of the aorta to re-line it. These customized stent-grafts have special branches attached to them or openings (called "fenestrations") that are used to keep blood flowing to the arteries that supply the liver, stomach, intestines and kidneys. The investigational stent graft will be designed and custom-made specifically for your aneurysm.

Experimental: Aortic Arch Study Arm

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.

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 cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively.

Outcome Measures

Primary Outcome Measures

Technical Success [Intraoperative]
Successful deployment of the TAAA device or Physician-Specified TAAA Devices, or Aortic Arch device & bridging covered stents into all targeted mesenteric & renal, or supra-aortic arteries with stent-graft & all branches patent by intraop angiography
Freedom from aneurysm-related mortality at 1 year [1 year]
Survival from aneurysm-related death.
Procedural Success [30 days]
Technical success plus freedom from type I or III endoleak, loss of target vessel patency, death, major stroke, paralysis, new onset permanent hemodialysis, major amputation, & bowel infarction following deployment of the branched stent-graft.

Secondary Outcome Measures

Target artery patency [Yearly through 5 years]
Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate target artery patency.
Freedom from all-cause mortality [Yearly through 5 years]
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.
Freedom from reintervention [Yearly through 5 years]
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation to determine if reintervention with the device is necessary.
Freedom from endoleak [Yearly through 5 years]
Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.
Freedom from aneurysm dilatation [Yearly through 5 years]
Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate aneurysm size.
Freedom from serious adverse events (SAE) and major complications [Yearly through 5 years]
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.
Freedom from aneurysm rupture and conversion to open repair [Yearly through 5 years]
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation to determine if aneurysm stability.
Freedom from stent graft migration and branch device migration [Yearly through 5 years]
Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Presbyterian Hospital	New York	New York	United States	10022
2	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104