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

Artivion

Status: Active, not recruiting

Conditions: Acute Aortic Dissection

Treatments: Device: AMDS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05174767

AMDS2101.000-C (02/21)

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

Acute DeBakey Type I Dissection

Experimental group

Description:

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:

Device: AMDS