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Medical Device

AMDS Device for Aortic Dissection (PERSEVERE Trial)

N/A

Recruiting

Led By Wilson Szeto, MD

Research Sponsored by CryoLife, Inc.

Eligibility Criteria Checklist

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

Must have

≥18 years of age or ≤80 years of age (male or female) at time of surgery

Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral)

Must not have

Any pathology of mycotic origin

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new medical device is safe and effective for treating a certain type of heart problem.

Who is the study for?

This trial is for adults aged 18-80 with acute DeBakey type I aortic dissection diagnosed within the past two weeks, showing malperfusion symptoms. Excluded are those institutionalized by order, with signs of bowel infarction or bleeding, severe infections, CT angiogram ineligibility, bleeding disorders, certain heart and vascular conditions, pregnancy/breastfeeding status, unwillingness to follow the study protocol or accept blood transfusions.

What is being tested?

The PERSEVERE trial is testing AMDS's safety and effectiveness in treating patients with acute DeBakey type I dissection through open surgical repair. It's a prospective (forward-looking), non-randomized study conducted across multiple centers.

What are the potential side effects?

While specific side effects of AMDS are not listed here, similar interventions may include risks such as infection at the surgery site, inflammation around the area where AMDS is applied, allergic reactions to materials used in AMDS like nitinol or polytetrafluoroethylene.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have poor blood flow to my brain, organs, or limbs.

Exclusion Criteria

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

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I have an infection caused by fungi.

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I have an abnormal connection between my aorta and another organ.

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I need surgery on my aorta or its branches as recommended by my doctor.

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I have poor blood flow in my heart's arteries.

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I do not have a medical condition that limits my life expectancy to less than 2 years.

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I have a bleeding disorder like hemophilia.

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My aortic arch aneurysm is larger than 50 mm.

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I have been diagnosed with Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome through genetic testing.

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I cannot get CT angiograms for follow-up.

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I have signs of severe bowel damage or bleeding in my stomach or intestines.

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My tear starts in the arch or beyond the left subclavian artery.

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I needed CPR at the time of screening due to a severe heart condition.

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I refuse to receive blood transfusions under any circumstances.

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I have not had any surgery or interventional procedures within the last 30 days.

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I have a body-wide infection.

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My chest artery is enlarged, measuring more than 45 mm.

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My kidney function is very low (Stage 5).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 30 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Primary Endpoint to Assess Distal Anastomotic New Entry (DANE) tears

Primary Endpoint to Assess Incidence of Major Adverse Events

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: Acute DeBakey Type I DissectionExperimental Treatment1 Intervention

In eligible patients, the ascending aorta is transected and removed in a routine standard of care manner utilizing hypothermic circulatory arrest; the operator will leave at least 10 mm (1.0 cm) aortic tissue proximal to the innominate artery. AMDS is pre-loaded onto the delivery system and is delivered into the true lumen through the open distal aorta and implanted according to the instructions for use.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AMDS

2017

N/A

~50

0 / 19Eligibility criteria met