Study of the Relay Pro® Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03090230|
Recruitment Status : Active, not recruiting
First Posted : March 24, 2017
Last Update Posted : May 16, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Other Specified Injury of Thoracic Aorta||Device: Relay Pro Thoracic Stent-Graft System||Not Applicable|
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 (Clinical Trial)|
|Actual 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)|
|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 :||November 2022|
|Estimated Study Completion Date :||November 2025|
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.
- Mortality post-procedure [ Time Frame: 30 days ]All-cause mortality at 30 days post-procedure
- 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.
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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
|United States, California|
|University of California, Irvine|
|Irvine, California, United States, 92868|
|Stanford, California, United States, 94305-5639|
|United States, Connecticut|
|Yale School of Medicine|
|New Haven, Connecticut, United States, 06510|
|United States, Georgia|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|United States, Indiana|
|Indiana University Health|
|Indianapolis, Indiana, United States, 46202|
|United States, Iowa|
|University of Iowa Hospital and Clinic|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center / Harvard Medical School|
|Boston, Massachusetts, United States, 02215|
|United States, Missouri|
|St. Louis University|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28203|
|United States, Ohio|
|Cleveland, Ohio, United States, 44106|
|United States, Pennsylvania|
|University of Pennsylvania Medical Center / Penn Presbyterian|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98105|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Ben Starnes, MD||University of Washington|
|Principal Investigator:||Ravi Rajani, MD||Emory University|
|Responsible Party:||Bolton Medical|
|Other Study ID Numbers:||
|First Posted:||March 24, 2017 Key Record Dates|
|Last Update Posted:||May 16, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
Descending Thoracic Aorta
Traumatic Injury of the Descending Thoracic Aorta
Wounds and Injuries