Optimized Strategies for Malperfusion Syndrome

NCT06532838 | Not Yet Recruiting DMC

• 1 other identifier: (2024) YLK-26
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Dissection

Keywords

Malperfusion syndrome; Aortic dissection; Optimized strategies; Central repair; Endovascular reperfusion

Outcome Measures

Primary Outcomes (1)

• Operative Mortality (OM)

  Patients who died within 30 days

  30-day

Secondary Outcomes (4)

• Rate of composite of Major Adverse Events (MAE)

  30-day

• Rate of composite of Major Adverse Pulmonary Events (MAPE)

  30-day

• Rate of reintervention

  3 year

• Mid-term survival

  3 year

Study Arms (2)

Optimized treatment strategies (OTS group)

EXPERIMENTAL

Patients randomized to OTS group will be treated with optimized treatment strategies.

Procedure: Optimized treatment strategies

Traditional treatment strategies (TTS group)

ACTIVE COMPARATOR

Patients randomized to TTS group will be treated with traditional treatment strategies.

Procedure: Traditional treatment strategies

Interventions

Optimized treatment strategies PROCEDURE

The 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.

Optimized treatment strategies (OTS group)

Traditional treatment strategies PROCEDURE

Immediate 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.

Traditional treatment strategies (TTS group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Patients are diagnosed with ATAAD, with a new diagnosis of malperfusion syndrome ,by meeting both of the following criteria:
• Radiographic findings reveal occlusion of the corresponding arteries (including either coronary artery, either carotid artery, celiac trunk, superior mesenteric artery or either iliac artery);
• Clinical features of end organ ischemia (altered consciousness, paralysis, melena, abdominal pain, tenderness to palpation, loss of sensory or motor function of the lower extremities) OR laboratory findings suggestive of end organ ischemia (elevated cardiac enzymes, lactate, myoglobin, or creatine kinase).

You may not qualify if:

• 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;
• Bilaterally fixed dilated pupils, hemorrhagic infarction or herniation of brain on admission;
• Cardiopulmonary arrest and required continuous uninterrupted cardiopulmonary resuscitation on admission;
• Irreversible multiple organ failure on admission;
• Life expectancy \< 1 year;
• Patients and (or) their families refused surgery;

Sponsors & Collaborators

• Xiamen Cardiovascular Hospital, Xiamen University: lead

Study Sites (1)

Xiamen Cardiovascular Hospital at Xiamen University

Xiamen, Fujian, 361008, China

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Cardiovascular Surgery, Principal Investigator, Clinical Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 1, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

CN (1)