CLINICAL TRIAL

Relay Pro Thoracic Stent-Graft System for Wounds

Waitlist Available · 18+ · All Sexes · Cleveland, OH

This study is evaluating whether a stent-graft can be used to treat people with traumatic injury of the descending thoracic aorta.

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About the trial for Wounds

Eligible Conditions
Aneurysm, Dissecting · Wounds and Injuries · Other Specified Injury of Thoracic Aorta

Treatment Groups

This trial involves 2 different treatments. Relay Pro Thoracic Stent-Graft System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Relay Pro Thoracic Stent-Graft System
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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 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
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.
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.
The length of the attachment zones will depend on the intended stent graft diameter.
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).
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 month, 6 months, 12 months, and annually through 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month, 6 months, 12 months, and annually through 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 month, 6 months, 12 months, and annually through 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Relay Pro Thoracic Stent-Graft System will improve 1 primary outcome and 15 secondary outcomes in patients with Wounds. Measurement will happen over the course of 30 days.

Mortality post-procedure
30 DAYS
All-cause mortality at 30 days post-procedure
30 DAYS
Successful device delivery and deployment
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.
DURING IMPLANTATION
Vascular access complications
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
DURING THE INITIAL IMPLANT ATTEMPT
All-cause mortality
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.
1 MONTH, 6 MONTHS, 12 MONTHS, AND ANNUALLY THROUGH 5 YEARS
Aortic expansion
1 MONTH, 6 MONTHS, 12 MONTHS, AND ANNUALLY THROUGH 5 YEARS
Aortic expansion (> 5mm) compared to the first post-procedural CT
1 MONTH, 6 MONTHS, 12 MONTHS, AND ANNUALLY THROUGH 5 YEARS
Major adverse events
1 MONTH, 6 MONTHS, 12 MONTHS, AND ANNUALLY THROUGH 5 YEARS
death, stroke, paralysis formation, or aortic expansion
1 MONTH, 6 MONTHS, 12 MONTHS, AND ANNUALLY THROUGH 5 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common side effects of relay pro thoracic stent-graft system?

The majority of common gastrointestinal side effects of the RELAY stent-graft system are not specific to this device. While side effects of the device are often severe, the RELAY stent-graft system performs well for treatment of aortic disease.

Anonymous Patient Answer

What are common treatments for wounds?

There are several noninvasive solutions that are used to treat traumatic and surgical injuries, such as wound stimulators to promote healing and topical medications. The use of wound stimulators is common, although the validity of clinical trials has been questioned.\n

Anonymous Patient Answer

What causes wounds?

There are many factors which can contribute to the formation of wounds, particularly in infants and children. Wounds are associated with an increased risk of local and systemic infections and will heal only by a combination of these forces. In adults, the environment plays a much more important part. Wounds are a complex part of life, and deserve a professional approach. It is recommended that a history of these wounds should be documented and that a full examination should be performed at each visit when necessary.

Anonymous Patient Answer

What are the signs of wounds?

Wounds may occur as small puncture wounds, deep cuts (1 cm or more in depth) that occur during surgery, sores (lesions from injuries), abrasions (smaller puncture wounds than sores), and scars (remnants of surgery including any wound edges). The location, size, number, and depth of lesions from wounds is extremely important, and dictates wound management. The signs of wounds can be used as indicators for what type of wound treatment is needed. These signs depend on the condition of the surrounding skin, such as if the skin has dried up or has turned yellow. Once you've determined the location and type of wound, determine the severity of the injury: 1.

Anonymous Patient Answer

What is wounds?

Wounds are one of the most common causes of long-term functional disability. Patients and caregivers need accurate and prompt information about wound management and therapy before they need to leave the hospital to return to a long-term home or nursing facility.

Anonymous Patient Answer

Can wounds be cured?

There are many causes of incisional question: Do high doses of topical metoclopramide produce sustained analgesia in a rabbit model of postoperative answer: We concluded that high doses of topical metoclopramide produce sustained analgesia in a rabbit model of question: Do topical corticosteroids inhibit chronic wound healing independent of wound area? answer: Corticosteroid can be used for many indications, but there are no current studies assessing the efficacy of topical corticosteroids in the chronic wound setting.

Anonymous Patient Answer

How many people get wounds a year in the United States?

About 60% of the wounds seen at US military emergency rooms are associated with penetrating injuries. Most injuries occur in males ages 35 to 65 years old. Injury severity increases with age up to age 92 years old. This is in sharp contrast to the 5-year survival rate from the US Bureau of Labor Statistics, in which nearly half of all deaths are from noninjury.

Anonymous Patient Answer

What does relay pro thoracic stent-graft system usually treat?

The system has been in use for many years in both Europe and the United States and, with a new valve design, is still widely used for treating thoracoapical aortic disease.

Anonymous Patient Answer

What is relay pro thoracic stent-graft system?

The ProThro system is a simple and efficacious option for thoracic endovascular treatment of thoracoabdominal aortic aneurysms and dissections. With no need for additional tools or access into the descending or thoracic aorta, this system is safe and easily learned and applied, making it desirable as a device for novice and experienced endovascular surgeons alike.

Anonymous Patient Answer

How serious can wounds be?

Complicated wounds can cause serious consequences if not treated. There are three categories of complications and they include septicaemia, deep infection, and deep organ damage. If you are looking to join a clinical trial, [Power] can help you find more details to make up your mind about joining a clinical trial.

Anonymous Patient Answer

Have there been other clinical trials involving relay pro thoracic stent-graft system?

There have been no documented clinical reports regarding the use of PTA-DGS in thoracic interventions. Our small series of patients had high success rates when using this system for complex thoracic interventions. Based on its safety and low rate of complications, we would recommend applying this system to new thoracic applications. For example, treating a pulmonary fistula associated with pleural empyema and mediastinal masses; this would be a challenging case that would be difficult to treat via conventional surgical approaches because of severe pleural scarring created by previous mediastinal surgeries (i.e., pleural empyema). The PTA-DGS could be successful in such a setting.

Anonymous Patient Answer

Have there been any new discoveries for treating wounds?

The last 30 years we have seen countless advances across all fields of medicine including wound healing and dermatology but new advances have been seen in many areas of wound healing. Current medical technology and therapies need to be investigated further to determine if it will allow current patients with injuries to heal better and more quickly. To start, it is advised for patients to not use their current treatments unless they do not have the necessary instructions for them.

Anonymous Patient Answer
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