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

Not Applicable

Recruiting

• Conditions: Acute Aortic Dissection

• Registration Number: NCT05174767
• Lead Sponsor: Artivion Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint to Assess Incidence of Major Adverse Events;Primary Endpoint to Assess Distal Anastomotic New Entry (DANE) tears