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

NCT ID: NCT02323581

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2033-12-31

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.

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.

Conditions

Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm, Thoracic; Aortic Dissection, Thoracoabdominal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAAA (thoracoabdominal aortic aneurysm) 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.

Group Type: EXPERIMENTAL

Endovascular treatment of Thoracoabdominal Aortic Aneurysm

Intervention Type: DEVICE

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.

Aortic Arch Study Arm

Physician-specified aortic arch stent graft device with up to 3 antegrade and/or retrograde branches or 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.

Group Type: EXPERIMENTAL

Endovascular treatment of Aortic Arch Aneurysms

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Presence of TAAA in:

1. Men with TAAA greater than or equal to 6 cm in diameter

2. Women with TAAA greater than or equal to 5 cm in diameter

3. Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year

4. Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or

5. Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter

2. Life expectancy more than 2 years

3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol

4. Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":

1. Proximal aortic landing zone:

• ≥ 20mm long
• ≤ 40mm and ≥ 20mm diameter in parallel aorta
• free from circumferential thrombus
• ≤ 60 degrees angulation

2. Mesenteric/renal aortic diameter ≥ 20mm

3. Mesenteric arteries:

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

4. Renal arteries:

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

5. Iliac artery access:

• ≥ 6mm diameter, and absence of severe calcification and tortuosity
• Or, planned creation of surgical conduit for TAAA device delivery

6. 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

5. Patients deemed high risk for open repair (meeting one, or more, of the following criteria):

1. Age ≥ 65 year

2. 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)

3. Pulmonary disease:

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

4. Renal disease:

• ESRD on dialysis
• eGFR < 60

5. Prior aortic surgery

6. Hostile abdomen

7. Portal hypertension (ascites or varices)

8. Coagulopathy

AORTIC ARCH STUDY ARM

1. Presence of aortic arch aneurysm in:

1. Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or

2. Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or

3. Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm/year, or

4. Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm/year, or

5. Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation

2. Life expectancy more than 2 years

3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol.

4. Suitable arterial anatomy for endovascular aortic arch repair with "Aortic Arch Device":

1. Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass

2. 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

3. 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

4. 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

5. Iliac artery access:

• ≥ 6mm diameter, and absence of severe calcification and tortuosity
• Or, planned creation of surgical conduit for TAAA device delivery

5. 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):

1. Age > 70 years-old

2. Prior ascending or aortic arch repair

3. Multiple (≥2) median sternotomies

4. Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test

5. Chronic pulmonary disease with FEV1 < 1500ml

6. Chronic kidney disease with eGFR ≤ 60 ml/kg/hr

7. Large aneurysm abutting the sternotomy

8. Severe deconditioning or immobility

9. Prior cervical irradiation

10. 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

1. Rupture, with hypotension (systolic bp < 90).

2. Pregnancy or breastfeeding.

3. Unwillingness or inability to comply with the follow up schedule.

4. Serious systemic or groin infection.

5. Uncorrectable coagulopathy.

6. Age < 18 years.

7. Mycotic aneurysm.

8. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).

9. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold.

10. Participation in another in another investigational device or drug study within 1 year of treatment.

11. 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)

12. Body habitus that would inhibit X-ray visualization of the aorta.

13. Acute aortic dissection

14. Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Darren Schneider, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Darren Schneider, M.D.

Chief, Vascular Surgery and Endovascular Therapy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Darren Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

New York Presbyterian Hospital

New York, New York, United States

Site Status: ACTIVE_NOT_RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Darren Schneider, MD

Role: CONTACT

Darren.Schneider@Pennmedicine.upenn.edu

215-614-0243

Kiera Zehner

Role: CONTACT

kiera.zehner@pennmedicine.upenn.edu

(412) 737-2572

Facility Contacts

Darren Schneider, MD

Role: primary

darren.schneider@pennmedicine.upenn.edu

215-614-0243

Kiera Zehner

Role: backup

kiera.zehner@pennmedicine.upenn.edu

(412) 737-2572

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Other Identifiers

843522

Identifier Type: -

Identifier Source: org_study_id