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

Status: Active, not recruiting
Location: See all (16) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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)

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

• 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.

• 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).

• 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

Locations
United States
California
University of California, Irvine
Irvine
Stanford Medicine
Stanford
Connecticut
Yale School of Medicine
New Haven
Georgia
Grady Memorial Hospital
Atlanta
Iowa
University of Iowa Hospital and Clinic
Iowa City
Indiana
Indiana University Health
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center / Harvard Medical School
Boston
Maryland
University of Maryland Medical Center
Baltimore
Missouri
St. Louis University
Saint Louis
North Carolina
Atrium Health
Charlotte
Ohio
University Hospitals
Cleveland
Pennsylvania
University of Pennsylvania Medical Center / Penn Presbyterian
Philadelphia
Tennessee
Vanderbilt University Medical Center
Nashville
Virginia
University of Virginia
Charlottesville
Washington
University of Washington
Seattle
Wisconsin
Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: April 17, 2017
Estimated Completion Date: November 2025
Participants
Target number of participants: 50
Treatments
Experimental: Relay Pro Thoracic Stent-Graft System
The Relay Pro arm includes subjects who receive the device to treat traumatic injury of the descending thoracic aorta with the RelayPro Thoracic Stent-Graft System
Sponsors
Leads: Bolton Medical

This content was sourced from clinicaltrials.gov