Clinical trial NCT03090230: Study of the Relay Pro® Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta
Official title: A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Other Specified Injury of Thoracic Aorta
Keywords: Descending Thoracic Aorta
DTA
Transection
Traumatic Injury of the Descending Thoracic Aorta
Lead sponsor: Bolton Medical
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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. All subjects enrolled, will be included in the patient population for the primary analysis. All subjects implanted with the RelayPro Thoracic Stent-Graft will be included in the patient population for the secondary analyses.
Primary purpose: TREATMENT

Brief 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)

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality post-procedure
timeFrame: 30 days
Secondary outcomes:
measure: Successful device delivery and deployment
timeFrame: During Implantation
measure: Loss of stent-graft patency
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Aortic rupture
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Stent fractures in the attachment zone
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Endoleaks
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Compression of stent-graft
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Erosion and/or extrusion
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Aortic expansion
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Endograft infection
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Incidence of open or endovascular secondary interventions
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Migration
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Major adverse events
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Aortic-related death
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
measure: Vascular access complications
timeFrame: During the initial implant attempt
measure: All-cause mortality
timeFrame: 1 month, 6 months, 12 months, and annually through 5 years
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Stanford
country: United States
facility: Stanford Medicine
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinic
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center / Harvard Medical School
state: Massachusetts
city: St Louis
country: United States
facility: St. Louis University
state: Missouri
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center / Penn Presbyterian
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Washington
name: Ben Starnes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Ravi Rajani, MD
role: PRINCIPAL_INVESTIGATOR
References: