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.