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New treatment option for Acute Type A Aortic Dissection
Official title Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection
ClinicalTrials.gov ID: NCT07150559
What this study is testing
- What it's testing
- The study is a multicenter, three-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 306 participants diagnosed with acute type A aortic dissection (ATAAD) from 7 hospitals in China. All patients receive total arch replacement (TAR) combined with frozen elephant trunk (FET) implantation and are randomized to Group 1 (arch-clamping technique under mild hypothermia), Group 2 (arch-clamping technique under moderate hypothermia) and Group 3 (Sun's procedure using bilateral antegrade cerebral perfusion) in the ratio of 1:1:1.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Aortic CTA confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
- Adult patients (18-70 years) weighing 50-120 kg;
- Time interval between the onset of symptoms and operation is less than 14 days;
- Indications for total aortic arch replacement are available;
- Signed informed consent and availability for follow-up.
You likely can't join if
- History of chronic renal failure, hepatocirrhosis, and hepatic insufficiency;
- Severe gastrointestinal complications of non-aortic dissection, such as mesenteric ischemia, gastrointestinal bleeding, hepatopancreaticobiliary...
- History of severe cerebral infarction (with cerebral infarction sequels);
- Preoperative intubation or unconsciousness;
- Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
- History of infectious aortic diseases;
See the full eligibility criteria
- Aortic CTA confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
- Adult patients (18-70 years) weighing 50-120 kg;
- Time interval between the onset of symptoms and operation is less than 14 days;
- Indications for total aortic arch replacement are available;
- Signed informed consent and availability for follow-up.
- History of chronic renal failure, hepatocirrhosis, and hepatic insufficiency;
- Severe gastrointestinal complications of non-aortic dissection, such as mesenteric ischemia, gastrointestinal bleeding, hepatopancreaticobiliary dysfunction, and intestinal obstruction;
- History of severe cerebral infarction (with cerebral infarction sequels);
- Preoperative intubation or unconsciousness;
- Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
- History of infectious aortic diseases;
- History of cardiac and aortic surgery;
- History of malignancy or previous radiotherapy;
- Pregnant or feeding women, or anyone planning to reproduce during the test period;
- Without an informed consent signature;
- Participating in any other clinical trial;
- Having other causes not eligible for operation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.