A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection

Status: Active, not recruiting
Location: See all (32) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.

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

• Subject must have an acute (symptom onset to diagnosis within 2 weeks)or subacute, complicated type B aortic dissection (entire dissection is distal to the left subclavian artery (LSA)), confirmed by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiogram (MRA), with time from symptom onset to diagnosis ≤ 6 weeks, with at least one of the following:

• Malperfusion of the viscera, kidneys, spinal cord, or lower extremities, measured by clinical or radiographic evidence;

• Rupture;

• Intractable pain.

• Proximal and distal aortic neck with diameter between 19 mm and 42 mm.

• Subject's anatomy must meet all of the following anatomical criteria:

• Proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery. (Dissection is permitted in the distal attachment zone but is not permitted in the proximal attachment zone.)

• The length of the attachment zones will depend on the intended stent-graft diameter and type of graft selected.

• The proximal attachment zone should be 15 mm for 22 - 28 mm RelayPro grafts with bare stent (20 mm for RelayPro grafts with non-bare stent), 20 mm for 30 - 46 mm RelayPro grafts with bare stent (25 mm for RelayPro grafts with non-bare stent), and proximal to non-dissected segment (healthy zone).

• The distal attachment zone should be 20 mm for all RelayPro grafts.

• Coverage of the left subclavian artery is permitted with mandatory revascularization if patent left internal mammary artery (LIMA) bypass or left upper extremity (LUE) arteriovenous graft or anomalous vertebral artery off the aorta. Revascularization must be performed prior to device placement, and may occur during implant procedure, provided it is before coverage of the LSA by the endograft.

• Proximal attachment zone containing a straight segment (non-tapered, non-reverse-tapered, defined by <10% diameter change) with lengths equal to or greater than the required attachment length for the intended device.

• Vascular dimensions (e.g., aortic diameters, length from left subclavian to celiac artery) must be in the range that can be safely treated with the RelayPro Thoracic Stent-Grafts.

• Adequate iliac or femoral artery access for introduction of the RelayPro Delivery System. Alternative methods to gain proper access may be utilized (e.g., iliac conduit).

• Subject willing to comply with the follow-up evaluation schedule.

• Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent Form prior to treatment.

Locations
United States
California
Long Beach Memorial Hospital
Long Beach
University of California at Los Angeles (UCLA)
Los Angeles
USC Department of Surgery
Los Angeles
Stanford
Stanford
Colorado
University of Colorado Denver
Aurora
Connecticut
Hartford Hospital
Hartford
Yale School of Medicine
New Haven
Washington, D.c.
Medstar Washington Hospital Center
Washington
Georgia
Emory University
Atlanta
Iowa
University of Iowa Hospital and Clinic
Iowa City
Illinois
Northwestern Memorial Hospital
Chicago
Indiana
St. Vincent Heart Center
Indianapolis
Maryland
University of Maryland Medical Center (UMB)
Baltimore
Michigan
University of Michigan Health System
Ann Arbor
North Carolina
Atrium Health (Sanger Heart & Vascular)
Charlotte
New Jersey
Newark Beth Israel Med Ctr / Saint Barnabas Med Ctr
Newark
New York
Buffalo General Medical Center
Buffalo
Columbia University Medical Center
New York
Ohio
Cleveland Clinic Foundation
Cleveland
University Hospitals
Cleveland
Oregon
Providence Heart Institute
Portland
Pennsylvania
University of Pennsylvania Medical Center / Penn Presbyterian
Philadelphia
Lankenau Medical Center
Wynnewood
South Dakota
North Central Heart
Sioux Falls
Tennessee
CVA Heart Institute
Kingsport
Vanderbilt University Medical Center
Nashville
Texas
Cardiothoracic and Vascular Surgeons
Austin
University of Texas Houston- Memorial Hermann Texas Medical Center
Houston
Virginia
Sentara Heart Hospital
Norfolk
Carilion Roanoke Memorial Hospital
Roanoke
Washington
University of Washington
Seattle
Wisconsin
Medical College of WI, Vascular Surgery
Milwaukee
Time Frame
Start Date: December 14, 2017
Estimated Completion Date: March 31, 2027
Participants
Target number of participants: 56
Treatments
Experimental: Experimental: Relay Pro
The Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections.
Authors
Sponsors
Leads: Bolton Medical

This content was sourced from clinicaltrials.gov

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