PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection (NCT05174767) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
United States115 participantsStarted 2022-05-27
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 sur…
What they're measuring
1
Primary Endpoint to Assess Incidence of Major Adverse Events
Timeframe: Through 30 days
2
Primary Endpoint to Assess Distal Anastomotic New Entry (DANE) tears