A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch

Status: Recruiting
Location: See all (30) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Male and female age ≥ 18.

• Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length

• Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter

• Distal/descending native landing zone of appropriate length

• Distal/descending native landing zone of appropriate diameter

• Brachiocephalic trunk native landing zone of appropriate length

• Brachiocephalic trunk native landing zone of appropriate diameter

• Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch perpendicular

• Appropriate aortic arch perpendicular diameter

• Chronic dissection with at least one of the following conditions:

• An aortic aneurysm with a maximum diameter ≥ 55 mm

• Rapidly expanding false lumen (growth of > 0.5 cm/6 months)

• Compressed true lumen associated with end organ malperfusion

• Symptomatic

• Aneurysm with at least one of the following conditions:

• Dilatation of the aortic arch larger than 5 cm in diameter for subject with fusiform aneurysm

• Dilatation of the aortic arch is 1.5 times the normal diameter for subjects ascending or descending

• Dilation of the aortic arch larger than 2.5 cm for subject with saccular aneurysm

• Symptomatic aneurysm of the aortic arch

• Aortic diameter growth rate > 5mm per 6 months

• Postoperative pseudoaneurysm expanding from anastomotic suture lines

• Penetrating aortic ulcer with at least one of the following:

• Symptomatic

• Ulcer demonstrates expansion

• Intramural hematoma with at least one of the following:

• Symptomatic (persistent pain)

• Transverse or longitudinal expansion on serial imaging

• In the event of a lesion in the ascending aortic, the proximal/ascending native or previously implanted surgical graft the landing zone must be appropriate

• Femoral / iliac artery diameter as documented by CTA or MRA that allows endovascular access to the diseased site with a 20 Fr. delivery catheter.

• Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA/MRA.

• Brachial/Axial Artery diameter that allows endovascular access suitable for 7 Fr.

• Subject is considered an appropriate candidate for an elective surgery.

• Subject is considered to be at high risk for open repair, as determined by the investigator.

• Access vessels, iliac/femoral & brachial/axillary compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and /or accessories.

• Subject is willing and able to comply with procedures specified in the protocol and is able to return for follow-up visits as specified by the protocol.

Locations
United States
Alabama
University of Alabama Birmingham
Recruiting
Birmingham
California
University of California San Diego Medical Center
Recruiting
La Jolla
UC Davis Health
Recruiting
Sacramento
Stanford University School of Medicine
Recruiting
Stanford
Colorado
University of Colorado
Recruiting
Aurora
Connecticut
Hartford Healthcare
Recruiting
Hartford
Georgia
Emory University
Recruiting
Atlanta
Illinois
The University of Chicago
Recruiting
Chicago
Indiana
Ascension St. Vincent
Recruiting
Carmel
Massachusetts
Tufts Medical Center
Recruiting
Boston
Maryland
University of Maryland
Recruiting
Baltimore
Michigan
University of Michigan
Recruiting
Ann Arbor
Missouri
Washington University School of Medicine
Recruiting
Saint Louis
North Carolina
Atrium Health
Recruiting
Charlotte
Duke University Medical Center
Recruiting
Durham
New York
Northwell Health Lenox Hill Hospital
Recruiting
New York
Ohio
The Lindner Research Center
Recruiting
Cincinnati
University Hospital
Recruiting
Cleveland
Oregon
Oregon Health
Recruiting
Portland
Pennsylvania
University of Pennsylvania
Recruiting
Philadelphia
Lankenau Medical Center
Recruiting
Wynnewood
South Carolina
Medical University of South Carolina
Recruiting
Charleston
Tennessee
Ballad Health
Recruiting
Kingsport
Vanderbilt University Medical Center
Recruiting
Nashville
Texas
Baylor Scott and White
Recruiting
Plano
Virginia
Sentara Norfolk General Hospital
Recruiting
Norfolk
Carilion Clinic
Recruiting
Roanoke
Washington
MedStar Washington Hospital
Recruiting
Northwest
University of Washington Medical Center
Recruiting
Seattle
Other Locations
New Zealand
Auckland City Hospital
Recruiting
Auckland
Contact Information
Primary
Jessica Kleine
j.Kleine@endospan.com
(612)2800208
Backup
Jennifer Miller
j.miller@endospan.com
Time Frame
Start Date: October 20, 2020
Estimated Completion Date: January 2027
Participants
Target number of participants: 100
Treatments
Experimental: Chronic Dissection
Experimental: Aneurysm
Experimental: Penetrating Aortic Ulcer and/or Intramural Hematoma
Authors
Sponsors
Leads: Endospan Ltd.

This content was sourced from clinicaltrials.gov

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