PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection

Study Overview
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Brief Summary
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Prospective, non-randomized, multicenter clinical investigation to assess the safety and effectiveness of AMDS in the treatment of patients with acute DeBakey type I dissection, with evidence of malperfusion, through open surgical repair.

Official Title
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A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE

Conditions
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Acute Aortic Dissection

Intervention / Treatment
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* Device: AMDS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age or ≤80 years of age (male or female) at time of surgery Acute DeBakey type I dissection based on computed tomography angiography (CTA) and diagnosed ≤14 days from of the index event Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral) Exclusion Criteria: Other medical condition that is associated with limited life expectancy <2 years (e.g., cancer, congestive heart failure) Pregnant or breastfeeding. Unwilling to comply with the follow-up schedule Institutionalized due to administrative or judicial order Unwilling to accept blood transfusions for any reason Coronary malperfusion In circulatory shock (i.e., systolic blood pressure <90 mmHg) at time of screening In extreme hemodynamic compromise requiring cardiopulmonary resuscitation at time of screening Suspicion of bowel necrosis (as determined by the implanting physician based on imaging observations, peritoneal signs, surgical exploration, elevated serum lactate levels, low pH, and/or acidosis) Clinical or radiographic signs of bowel infarction or gastrointestinal hemorrhage Base deficit > -10 mmol/L or -10 mEq/L American Society of Anesthesiologists risk class V (i.e., moribund patient not expected to live 24 hours with or without operation) or class VI (a declared brain dead patient whose organs are being removed for donor purposes) Previous placement of a thoracic endovascular graft Interventional and/or open surgical procedures 30 days prior to the dissection repair Planned major interventional and/or open surgical procedures 30 days post the dissection repair Systemic infection Uncontrollable anaphylaxis to iodinated contrast (patients with allergy to iodinated contrast but not anaphylaxis may be eligible with appropriate pre-medication, as deemed suitable by the Investigator) Known allergy(ies) to nitinol and/or polytetrafluoroethylene Inability to obtain CT angiograms for follow-up Previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, or Loeys-Dietz syndrome based on laboratory genetic testing Diagnosed with acute myocardial infarction in the 30 days prior to the dissection diagnosis Diagnosed with severe and catastrophic neurological complications in the 30 days prior to the dissection diagnosis (namely, obtundation or coma) Current Stage 5 end stage chronic kidney disease (eGFR ≤ 15 mL/min) History of bleeding disorder (i.e. hemophilia) A primary entry tear that extends into the arch or distal to the left subclavian artery Need for a total aortic arch replacement and/or repair, or reconstruction, of any part of the arch, and branch vessels (including extra-anatomic bypass of the branch vessels), for any reason as deemed necessary by the Investigator Any pathology of mycotic origin Aortic fistulous communication with non-vascular structure (e.g., esophagus, bronchial) Extensive thrombus or calcifications in the aortic arch, as defined by CTA Excessive tortuosity precluding safe passage of the AMDS, as defined by CTA Descending thoracic aneurysm involving the proximal third (one-third) of the descending aorta and measuring >45 mm in diameter Aortic arch aneurysm >50 mm in diameter

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute DeBakey Type I Dissection<br>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. | Device: AMDS<br>* AMDS Implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint to Assess Incidence of Major Adverse Events | Patients experiencing at least one of the following MAEs: All-cause mortality (ACM) New disabling stroke New onset renal failure requiring dialysis Myocardial infarction (MI) | Through 30 days | 
| Primary Endpoint to Assess Change in Maximal True Lumen (TL) diameter | Patients with clinically meaningful (≥ 6.0 mm) true lumen expansion (at 1-Year), as defined by: Change in maximal true lumen (TL) diameter in the aortic arch at Zone 3 (2 cm distal to the origin of the left subclavian artery) from pre-operative computed tomography angiogram (CTA) measurements on admission to 1-year CTA measurements without need for device-related aortic reintervention. | At 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Diseases, Cardiovascular Diseases, Aortic Dissection, Aortic Remodeling, Malperfusion, Acute, Acute Aortic Dissection