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

Part of paid clinical trials in New York, New York.

Sponsor
Darren Schneider, M.D.
Study ID
NCT02323581
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Aneurysm, Thoracic
  • Aortic Aneurysm, Thoracoabdominal
  • Aortic Dissection, Thoracoabdominal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endovascular treatment of Thoracoabdominal Aortic Aneurysm — 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.
  • Endovascular treatment of Aortic Arch Aneurysms — 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.

Study Details

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.

Key Dates

Start date
Nov 30, 2013
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2033

Study Design

Enrollment
520 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Technical Success [ Time Frame: Intraoperative ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
New York Presbyterian HospitalNew YorkNew York10022-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Darren Schneider, MD
[email protected]
215-614-0243
Kiera Zehner
[email protected]
(412) 737-2572
Darren Schneider, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
New York Presbyterian Hospital· New York, NYHospital of the University of Pennsylvania· Philadelphia, PA

Related Studies