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

• ClinicalTrials.gov Identifier: NCT03090230
• Recruitment Status: Active, not recruiting
• First Posted: March 24, 2017
• Last Update Posted: May 16, 2022
• Sponsor: Bolton Medical
• Information provided by (Responsible Party): Bolton Medical

Tracking Information

• First Submitted Date: March 7, 2017
• First Posted Date: March 24, 2017
• Last Update Posted Date: May 16, 2022
• Actual Study Start Date: April 17, 2017
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 20, 2017)

Mortality post-procedure [ Time Frame: 30 days ]

All-cause mortality at 30 days post-procedure

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 22, 2018)

• Successful device delivery and deployment [ Time Frame: During Implantation ]
  Successful delivery and deployment of the device, including withdrawal of the delivery system, will be assessed with angiography during the index procedure at the Treatment Visit.
• Loss of stent-graft patency [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Loss of stent-graft patency through 5 years
• Aortic rupture [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Aortic rupture will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media
• Stent fractures in the attachment zone [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Stent fractures in the attachment zone will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media
• Endoleaks [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft
• Compression of stent-graft [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Extra-luminal compression of the stent-graft will be assessed at each follow-up visit with xrays, CT scans, or MRIs for subjects unable to tolerate contrast media
• Erosion and/or extrusion [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Erosion and extrusion will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media
• Aortic expansion [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Aortic expansion (> 5mm) compared to the first post-procedural CT
• Endograft infection [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Infection of stent-graft
• Incidence of open or endovascular secondary interventions [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Incidence of open or endovascular secondary interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion
• Migration [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Stent migration (> 10 mm) compared to the first post-procedural CT; formation, or aortic expansion
• Major adverse events [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  death, stroke, paralysis formation, or aortic expansion
• Aortic-related death [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  formation, or aortic expansion
• Vascular access complications [ Time Frame: During the initial implant attempt ]
  The Time Frame for reporting is during the Treatment Visit. Data should be captured upon conclusion of the Treatment Visit. Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system
• All-cause mortality [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  All causes where subject death is the result of a serious and device- or procedure related adverse effect. Unrelated and accidental deaths, for example a subject death due to injuries sustained from a gunshot wound, would not be included in the evaluation.

Original Secondary Outcome Measures (submitted: March 20, 2017)

• Successful device delivery and deployment [ Time Frame: During Implantation ]
  Successful delivery and deployment of the device, including withdrawal of the delivery system, will be assessed with angiography during the index procedure at the Treatment Visit.
• Loss of stent-graft patency [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Loss of stent-graft patency through 5 years
• Aortic rupture [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Aortic rupture will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media
• Stent fractures in the attachment zone [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Stent fractures in the attachment zone will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media
• Endoleaks [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft
• Compression [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Compression
• Erosion and/or extrusion [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Erosion and extrusion will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media
• Aortic expansion [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Aortic expansion (> 5mm) compared to the first post-procedural CT
• Endograft infection [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Infection of stent-graft
• Incidence of open or endovascular secondary interventions [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Incidence of open or endovascular secondary interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion
• Migration [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  Stent migration (> 10 mm) compared to the first post-procedural CT; formation, or aortic expansion
• Major adverse events [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  death, stroke, paralysis formation, or aortic expansion
• Aortic-related death [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  formation, or aortic expansion
• Vascular access complications [ Time Frame: During the initial implant attempt ]
  The Time Frame for reporting is during the Treatment Visit. Data should be captured upon conclusion of the Treatment Visit. Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system
• All-cause mortality [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
  All causes where subject death is the result of a serious and device- or procedure related adverse effect. Unrelated and accidental deaths, for example a subject death due to injuries sustained from a gunshot wound, would not be included in the evaluation.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Other Specified Injury of Thoracic Aorta

Intervention

Device: Relay Pro Thoracic Stent-Graft System

RelayPro Thoracic Stent-Grafts are designed for the management of patients with aneurysms and penetrating ulcers within the descending thoracic aorta (DTA). The device is designed specifically for use in the thoracic aorta.

Study Arms

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

Intervention: Device: Relay Pro Thoracic Stent-Graft System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 20, 2017): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2025
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03090230
• Other Study ID Numbers: IP-0018-16
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Bolton Medical
• Original Responsible Party: Same as current
• Current Study Sponsor: Bolton Medical
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ben Starnes, MD; University of Washington
• Principal Investigator: Ravi Rajani, MD; Emory University

• PRS Account: Bolton Medical
• Verification Date: May 2022