Optimized Strategies for Malperfusion Syndrome
ConditionAortic Dissection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXiamen Cardiovascular Hospital, Xiamen University
About this trial
An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with acute type A aortic dissection (ATAAD) and malperfusion syndrome (MPS).
Objectives: The present study aimed to investigate the difference in all-cause mortality after optimized treatment strategies (OTS) versus traditional treatment strategies (TTS) for ATAAD patients with MPS.
Background: The mortality of ATAAD with MPS is high. However, the management strategies of MPS patients still not to be confirmed. Compare with TTS, OTS as a strategy for ATAAD patients with MPS might have be beneficial results.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of informed consent prior to any study specific procedures;
Acute type A aortic dissection is confirmed by computed tomography angiography;
The symptoms onset within 2 weeks;
Radiographic findings reveal occlusion of the corresponding arteries (including either coronary artery, either carotid artery, celiac trunk, superior mesenteric artery or either iliac artery);
Disqualifiers
Age <18 yr and >80 yr;
Unstable condition with cardiac tamponade or aortic rupture on admission;
Multiple types of malperfusion syndrome on admission;
Bloody stools or melena on admission;
Trial design
Design model
Parallel
Treatments tested in this trial
Optimized treatment strategies
Procedure/SurgeryThe optimized strategies based on 6-hour threshold from symptom onset. For malperfused patients with symptom onset within 6 hours, central repair will be performed immediately. Additional stenting will be used in patients with persistent malperfusion. For malperfused patients with symptom onset beyond 6 hours, individualized delayed central repair according to the different types of MPS will be performed after organ function improved and the patient could tolerate central repair.
Traditional treatment strategies
Procedure/SurgeryImmediate central repair will be performed for patients with coronary and cerebral malperfusion syndrome. However, for patients with mesenteric and lower extremity malperfusion syndrome, interventional therapy will be administered through fenestration and/or stenting to first alleviate organ ischemia. Once the patients had a resolution of organ failure, corrective open aortic repair will be performed.
Treatment groups
236 Participants
are divided into 2 treatment groupsGroup A: Optimized treatment strategies (OTS group)Experimental treatment 1 intervention
Group B: Traditional treatment strategies (TTS group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Operative Mortality (OM)
Patients who died within 30 days
Time frame
30-daySecondary outcomes
1
Rate of composite of Major Adverse Events (MAE)
Number of participants with MAE which will include the composite rate of low cardiac output syndrome, new cerebrovascular accident, intestinal ischemia, lower limb necrosis, multiple organ failure according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Time frame
30-day2
Rate of composite of Major Adverse Pulmonary Events (MAPE)
Number of participants with MAPE which will include the composite rate of intubation \>48 hours, pneumonia, reintubation, tracheostomy according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Time frame
30-day3
Rate of reintervention
The number of participants who will require reoperation for distal aorta
Time frame
3 year4
Mid-term survival
The secondary endpoint of the study is the evaluation of mid-term survival
Time frame
3 yearSponsors and contacts
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Source ClinicalTrials.gov
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