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

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ClinicalTrials.gov Identifier: NCT03090230
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bolton Medical

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)

Condition or disease Intervention/treatment Phase
Other Specified Injury of Thoracic Aorta Device: Relay Pro Thoracic Stent-Graft System Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
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
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : June 17, 2019
Estimated Study Completion Date : July 17, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Mortality post-procedure [ Time Frame: 30 days ]
    All-cause mortality at 30 days post-procedure


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Endograft infection [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
    Infection of stent-graft

  10. 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

  11. 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

  12. Major adverse events [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
    death, stroke, paralysis formation, or aortic expansion

  13. Aortic-related death [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years ]
    formation, or aortic expansion

  14. 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

  15. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090230


Contacts
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Contact: Lea Doyle 3523621021 ldoyle@BoltonMedical.com
Contact: Matthew Stark, Ph.D 954-626-5151 Mstark@BoltonMedical.com

Locations
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United States, California
University of California, Irvine Not yet recruiting
Irvine, California, United States, 92868
Principal Investigator: Carlos Donayre, MD         
Long Beach Memorial Hospital Not yet recruiting
Long Beach, California, United States, 90806
Principal Investigator: Ali Khoynezhad, MD         
University of California at Los Angeles (UCLA) Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Juan Carlos Jimenez, MD         
United States, Florida
University of Miami / Jackson Memorial Hospital Not yet recruiting
Miami, Florida, United States, 33136
Principal Investigator: Amit Patel, MD         
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Principal Investigator: Jaime Benarroch-Gampel, MD         
United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Joel Corvera, MD         
United States, Iowa
University of Iowa Hospital and Clinic Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Melhem Sharafuddin, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center / Harvard Medical School Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Marc Schermerhorn, MD         
United States, Missouri
St. Louis University Not yet recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Donald Jacobs, MD         
United States, New Jersey
Rutgers Robert Wood Johnson Medical Center Recruiting
New Brunswick, New Jersey, United States, 08901
Principal Investigator: Khanjan Nagarsheth, MD         
United States, Ohio
University Hospitals Recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Alexis Powell, MD         
United States, Pennsylvania
University of Pennsylvania Medical Center / Penn Presbyterian Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Venkat Kalapatapu, MD         
Lankenau Medical Center Not yet recruiting
Wynnewood, Pennsylvania, United States, 19096
Principal Investigator: Robert Meisner, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: John Fritz Angle, MD         
INOVA Fairfax Not yet recruiting
Falls Church, Virginia, United States, 22042
Principal Investigator: Liam Ryan, MD         
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98105
Principal Investigator: Benjamin Starnes, MD         
United States, West Virginia
West Virginia University Not yet recruiting
Morgantown, West Virginia, United States, 26505
Principal Investigator: Luke Marone, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: Pete Rossi, MD         
Sponsors and Collaborators
Bolton Medical
Investigators
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Principal Investigator: Ben Starnes, MD University of Washington
Principal Investigator: Ravi Rajani, MD Emory University

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Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT03090230     History of Changes
Other Study ID Numbers: IP-0018-16
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Bolton Medical:
Descending Thoracic Aorta
DTA
Transection
Traumatic Injury of the Descending Thoracic Aorta
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Wounds and Injuries
Aneurysm
Vascular Diseases
Cardiovascular Diseases