PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
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.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: AMDS
Eligibility
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
18 Years - 80 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.