Study of the Relay Pro® Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:2/24/2018
Start Date:April 17, 2017
End Date:July 17, 2024
Contact:Lea Doyle
Email:ldoyle@BoltonMedical.com
Phone:3523621021

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A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta

The purpose of this study is to investigate the safety and effectiveness of the RelayPro
Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta
(DTA)

This is a prospective, multicenter, non-blinded, non-randomized study of the RelayPro
Thoracic Stent-Graft in subjects with traumatic injury of the DTA in subjects who are
candidates for endovascular repair.The primary objective of the study is all-cause mortality
at 30 days post procedure.

The secondary objectives of the trial will include descriptive analyses of procedural and
post-procedural observations through 5 years of follow-up.

Inclusion Criteria:

- Age greater than 18 years

- Subject must have a traumatic injury of the descending thoracic aorta that occurred no
more than 30 days prior to the planned stent implant procedure

- Proximal and distal landing zones with diameter between 19 mm and 42 mm.

- Subject must have a proximal attachment zone distal to the left common carotid and a
distal attachment zone proximal to the origin of the celiac artery.

- The length of the attachment zones will depend on the intended stent graft diameter.

1. The proximal attachment zone should be: i. 15 mm for 22 - 28 mm grafts with bare
stent (20 mm for RelayPro grafts with non-bare stent). ii. 20 mm for 30 - 46 mm
grafts with bare stent (25 mm for RelayPro grafts with non-bare stent).

2. The distal attachment zone should be 20 mm for all Relay Pro grafts.

- Coverage of the left subclavian artery is permitted. Revascularization of the left
subclavian artery may be considered in all cases by the treating physician and,
especially, in anatomies where revascularization is determined to be clinically
necessary

- Proximal and distal attachment zones 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.

- 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

Exclusion Criteria:

- Significant stenosis, calcification, thrombus, or tortuosity of intended fixation
sites that would compromise fixation or seal of the device.

- Planned coverage of left carotid or celiac arteries; or anatomic variants that may
compromise circulation to the carotid, vertebral, or innominate arteries after device
placement, and are not amenable to subclavian revascularization

- Prior endovascular or surgical repair in the DTA. The device may not be placed within
any prior endovascular or surgical graft.

- Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal, aorta
requiring repair.

- Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed
less than 6 months prior to the planned stent implant procedure.

- Untreatable allergy or sensitivity to contrast media or device components.

- Known or suspected connective tissue disorder.

- Blood coagulation disorder or bleeding diathesis for which the treatment cannot be
suspended for one week pre- and/or post-repair.

- Coronary artery disease with unstable angina.

- Severe congestive heart failure (New York Heart Association functional class IV).

- Stroke and/or Myocardial Infarction within 3 months of the planned treatment date.

- Pulmonary disease requiring the routine (daily or nightly) need for oxygen therapy
outside the hospital setting.

- Acute renal failure or chronic renal insufficiency, and not receiving dialysis.

- Hemodynamically unstable.

- Active systemic infection and/or mycotic aneurysms.

- Morbid obesity or other condition that may compromise or prevent the necessary imaging
requirements.

- Injury Severity Score of 75.

- Less than two-year life expectancy.

- Current or planned participation in an investigational drug or device study that has
not completed primary endpoint evaluation.

- Currently pregnant or planning to become pregnant during the course of the study.

- Medical, social, or psychological issues that Investigator believes may interfere with
treatment or follow-up.
We found this trial at
18
sites
Los Angeles, California 90095
Principal Investigator: Juan Carlos Jimenez, MD
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Los Angeles, CA
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Iowa City, Iowa 52242
Principal Investigator: Melhem Sharafuddin, MD
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Iowa City, IA
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1611 Northwest 12th Avenue
Miami, Florida 33136
Principal Investigator: Amit Patel, MD
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Miami, FL
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Benjamin Starnes, MD
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Principal Investigator: Jaime Benarroch-Gampel, MD
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Atlanta, GA
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Boston, Massachusetts 02115
Principal Investigator: Marc Schermerhorn, MD
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from
Boston, MA
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: John Fritz Angle, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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Cleveland, Ohio 44106
Principal Investigator: Alexis Powell, MD
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Cleveland, OH
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Falls Church, Virginia 22042
Principal Investigator: Liam Ryan, MD
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Falls Church, VA
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Indianapolis, Indiana 46202
Principal Investigator: Joel Corvera, MD
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from
Indianapolis, IN
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Irvine, California 92697
949-824-5011
Principal Investigator: Carlos Donayre, MD
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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from
Irvine, CA
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Long Beach, California 90801
Principal Investigator: Ali Khoynezhad, MD
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Long Beach, CA
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Pete Rossi, MD
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Luke Marone, MD
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Morgantown, WV
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New Brunswick, New Jersey 08901
Principal Investigator: Khanjan Nagarsheth, MD
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New Brunswick, NJ
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3400 Civic Center Boulevard
Philadelphia, Pennsylvania 19104
Principal Investigator: Venkat Kalapatapu, MD
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Philadelphia, PA
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Saint Louis, Missouri 63110
Principal Investigator: Donald Jacobs, MD
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Saint Louis, MO
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Wynnewood, Pennsylvania 19096
Principal Investigator: Robert Meisner, MD
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Wynnewood, PA
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