CLINICAL TRIAL

Relay Pro Stent-Graft for Aortic Dissection

Recruiting · 18+ · All Sexes · Cleveland, OH

This study is evaluating whether a new type of stent may help treat aortic dissection.

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About the trial for Aortic Dissection

Eligible Conditions
Aneurysm, Dissecting · Type B Aortic Dissection

Treatment Groups

This trial involves 2 different treatments. Relay Pro Stent-Graft 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 Stent-Graft
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:
Proximal attachment zone 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.
Proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery. (Dissection is permitted in the distal attachment zone but is not permitted in the proximal attachment zone.)
Malperfusion of the viscera, kidneys, spinal cord, or lower extremities, measured by clinical or radiographic evidence;
Rupture;
Intractable pain.
Proximal and distal aortic neck with diameter between 19 mm and 42 mm.
The length of the attachment zones will depend on the intended stent-graft diameter and type of graft selected.
The proximal attachment zone should be 15 mm for 22 - 28 mm RelayPro grafts with bare stent (20 mm for RelayPro grafts with non-bare stent), 20 mm for 30 - 46 mm RelayPro grafts with bare stent (25 mm for RelayPro grafts with non-bare stent), and proximal to non-dissected segment (healthy zone).
The distal attachment zone should be 20 mm for all RelayPro grafts.
Coverage of the left subclavian artery is permitted with mandatory revascularization if patent left internal mammary artery (LIMA) bypass or left upper extremity (LUE) arteriovenous graft or anomalous vertebral artery off the aorta. Revascularization must be performed prior to device placement, and may occur during implant procedure, provided it is before coverage of the LSA by the endograft.
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1, 6, and 12 month follow-up visits, and annually through 5 years.
Screening: ~3 weeks
Treatment: Varies
Reporting: 1, 6, and 12 month follow-up visits, and annually through 5 years.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1, 6, and 12 month follow-up visits, 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 Stent-Graft will improve 1 primary outcome and 3 secondary outcomes in patients with Aortic Dissection. Measurement will happen over the course of 30 days.

All-cause mortality post-procedure
30 DAYS
All-cause mortality 30 days post-procedure
30 DAYS
Technical Success at the time of the index procedure
DURING DEPLOYMENT OF THE DEVICE
Successful delivery and deployment of the device, including withdrawal of the delivery system;
DURING DEPLOYMENT OF THE DEVICE
Treatment success through 1 month
1 MONTH, 6 MONTHS, 12 MONTHS, AND ANNUALLY THROUGH 5 YEARS, DEFINED AS INDIVIDUAL ENDPOINTS AND AS A COMPOSITE
Absence of Major adverse Event (MAE) Absence of relevant MAEs: Paraplegia; Paraparesis; New ischemia due to branch vessel compromise; Absence of unintentional rupture of the dissection septum;
1 MONTH, 6 MONTHS, 12 MONTHS, AND ANNUALLY THROUGH 5 YEARS, DEFINED AS INDIVIDUAL ENDPOINTS AND AS A COMPOSITE
Dissection Treatment Success
1, 6, AND 12 MONTH FOLLOW-UP VISITS, AND ANNUALLY THROUGH 5 YEARS.
• Dissection treatment success through 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite
1, 6, AND 12 MONTH FOLLOW-UP VISITS, AND ANNUALLY THROUGH 5 YEARS.

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 signs of aortic dissection?

This is a very uncommon presentation and its clinical and radiological features are similar to aortic dissection. Early detection of this disorder can prevent serious complications and mortality.

Anonymous Patient Answer

Can aortic dissection be cured?

The mortality of the group diagnosed with aortic dissection after 1 year was 50%, and after 2 years was 87%. The survival of the individuals with aortic dissection was good but there was a high mortality even after the operation.

Anonymous Patient Answer

How many people get aortic dissection a year in the United States?

Only 50,000-100,000 per year are diagnosed with aortic dissection. The actual number of people being treated or killed is probably much higher. Most deaths from ruptured aorta occur in the infrarenal aorta and not the aorta proper.

Anonymous Patient Answer

What causes aortic dissection?

Patients with symptomatic aortic dissection present with the classic signs and symptoms of aortitis, including dissection. Dissection must be ruled out before surgical treatment is considered. The risk of surgical intervention is low, and most dissections can be managed by observation. Asymptomatic dissections are typically diagnosed based on signs and symptoms, regardless of aortitis status. Patients with asymptomatic dissections are less likely to undergo surgical intervention.

Anonymous Patient Answer

What are common treatments for aortic dissection?

Acute treatment for acute aortic dissection is surgical repair of the aortic dissection. It is essential to obtain prompt surgical repair of acute aortic dissection.

Anonymous Patient Answer

What is aortic dissection?

Aortic dissections are rare in children. The most common types in children are idiopathic and traumatic. Older children are more likely to present with dissection in the ascending, rather than in the aortic arch. As compared with older children, younger children are at lower risk of having a thoracic aortic dissection due to their greater proportion of body weight in the left sided thorax. Thoracic aortic dissection was more common in girls, had an earlier age of onset, and had a higher incidence of cardiac disease than a trisectoral aortic dissection. Aortic dissection was most common in the left anterior descending artery.

Anonymous Patient Answer

What is relay pro stent-graft?

In patients with coexistent renal insufficiency, pre-procedural creatinine clearance had significant influence on the long-term clinical outcome of AVEG, and these results should be taken into consideration in patient selection for this procedure.

Anonymous Patient Answer

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

Relay PS-G can be performed on both sides. If there are no serious complications, it can be performed successfully on both the left side and the right atrial side with satisfactory results.

Anonymous Patient Answer

Does aortic dissection run in families?

A high percentage of aortic dissection presenting as Marfan syndrome is estimated to be genetically linked. Heterozygous mutation detection rates of AS are estimated to be similar to those reported for autosomal recessive mutations or even greater as suggested by the higher mutation frequencies of AS. This is based on heterozygotes frequency estimates from published studies and indicates that AS may be underdiagnosed in some families.

Anonymous Patient Answer

Have there been any new discoveries for treating aortic dissection?

There have been some recent breakthroughs in our understanding of the pathophysiology of aortic dissection, which has helped in providing treatments that are potentially effective in reducing morbidity and mortality. The identification of a new target for pharmacotherapy is important for those with aortic dissection because current treatment options are not ideal.

Anonymous Patient Answer

What is the average age someone gets aortic dissection?

Onset can occur at any age. The average age is 57 years. The male-to-female ratio is 1:1.3. There is an association between aortic dissection and congenital disorders. This is because the risk of developing the dissection is increased by the mutation of those genes.

Anonymous Patient Answer

Who should consider clinical trials for aortic dissection?

Patients should consider clinical trials for AVAD. Patients can benefit from such trials by gaining knowledge of the risk profiles, disease processes, and treatment options. Clinical trials can help refine the management and treatment of patients to help reduce mortality, morbidity, and complications associated with the disease.

Anonymous Patient Answer
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