What is the mechanism of action of this treatment?

The most common treatments for Aortic Dissection, such as the Aortic Dissection Stent (AMDS), work by providing structural support to the damaged aorta and facilitating the healing process. These stents are designed to reinforce the weakened sections of the aorta, preventing further tearing and promoting the reformation of the vessel's integrity. This is crucial for Aortic Dissection patients as it helps to stabilize the aorta, reduce the risk of rupture, and improve overall outcomes by allowing the aorta to heal more effectively. By maintaining the structural integrity of the aorta, these treatments can significantly reduce mortality and morbidity associated with Aortic Dissection.

What side effects are associated with this type of intervention?

The most common treatments for aortic dissection, such as endovascular repair and the use of stent-grafts like the AMDS, can have several side effects. These include the risk of endoleak (persistent blood flow outside the stent graft but within the aneurysm sac), device migration, stent-graft infolding or collapse, and potential rupture of the treated aneurysm. Other complications may involve ischemia, particularly if the left subclavian artery is covered without revascularization, leading to functional impairment of the left arm. Additionally, there is a risk of pleural effusions and, in rare cases, fatal complications such as stent-graft erosion into the esophagus.

What prior FDA approvals exist?

The FDA has approved several endovascular stent-grafts for the treatment of aortic dissection, which provide structural support and facilitate healing in the aorta. Notable examples include the GORE TAG Thoracic Branch Endoprosthesis, which is used for thoracic aortic aneurysms and dissections. These devices are designed to reinforce the aortic wall, prevent rupture, and promote proper blood flow, similar to the objectives of the AMDS trial.

What other types of research exist?

Promising novel alternatives to AMDS for aortic dissection patients include next-generation stent grafts specifically designed for ascending and arch aortic lesions, such as those evaluated in recent studies. Additionally, hybrid surgical techniques that combine open surgery with endovascular repair have shown favorable midterm and long-term outcomes. These approaches offer structural support and facilitate healing in the aorta, providing viable options for treatment in 2024.

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Aortic Stent Graft

AMDS for Aortic Dissection (DARTS I Trial)

N/A

Waitlist Available

Led By Michael Moon, MD

Research Sponsored by Ascyrus Medical LLC.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Medical Exclusion Criteria: Previously diagnosed with Marfan syndrome, Loeys- Dietz syndrome or Ehlers- Danlos syndrome with confirmed laboratory genetic testing on a date prior to the diagnosis of the dissection

Anatomical Exclusion Criteria: Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up annually, through study completion, an average of 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special device called AMDS used during surgery to fix serious tears in the main artery of the heart. It targets adults with severe artery tears or bleeding. The device works by holding the artery together and covering the damaged area to help it heal.

Who is the study for?

This trial is for adults under 80 with a recent (0-14 days) acute DeBakey type I dissection or intramural hematoma based on CT angiography. Excluded are those allergic to Nitinol/PTFE, in severe hemodynamic compromise, pregnant/breastfeeding, unwilling to follow up, with systemic infections, anaphylaxis to iodinated contrast, life expectancy <2 years, certain genetic syndromes or extensive aortic arch issues.

What is being tested?

The DARTS I study tests the AMDS device's feasibility and benefits for open surgical repair of acute DeBakey type I dissections/intramural hematomas involving the ascending aorta and arch. It aims to understand how well this treatment works in these emergency conditions.

What are the potential side effects?

While specific side effects of AMDS aren't listed here, similar devices may cause complications like infection risk at the surgery site, bleeding issues due to blood vessel damage during insertion or removal of the device.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not been diagnosed with Marfan, Loeys-Dietz, or Ehlers-Danlos syndrome before my current condition.

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I do not have an abnormal connection between my aorta and non-blood vessel structures.

Select...

I have not needed CPR for severe heart or lung problems recently.

Select...

I do not have any infections caused by fungi.

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My aorta does not have an aneurysm larger than 45mm in its upper part.

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I am between 18 and 80 years old.

Select...

I do not have any ongoing infections that aren’t responding to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ annually, through study completion, an average of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~annually, through study completion, an average of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and annually, through study completion, an average of 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with device-related mortality

Number of participants with neurological complications (TIA, stroke)

Secondary study objectives

Assess need for stent removal

Successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device

Successful reattachment of the intimal flap within the arch

+1 more

Other study objectives

AMDS related re-interventions after the dissection repair

Aortic arch branch vessel patency

Aortic injury associated with the implantation of the device

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AMDS ImplantationExperimental Treatment1 Intervention

AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AMDS

2017

N/A

~50

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Aortic Dissection, such as the Aortic Dissection Stent (AMDS), work by providing structural support to the damaged aorta and facilitating the healing process. These stents are designed to reinforce the weakened sections of the aorta, preventing further tearing and promoting the reformation of the vessel's integrity. This is crucial for Aortic Dissection patients as it helps to stabilize the aorta, reduce the risk of rupture, and improve overall outcomes by allowing the aorta to heal more effectively. By maintaining the structural integrity of the aorta, these treatments can significantly reduce mortality and morbidity associated with Aortic Dissection.