Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair

NCT03347812 | Unknown DMC

• 1 other identifier: D171100002917004
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 4

Brief Summary

Aortic disease is a kind of cardiovascular diseases with very high mortality rate and high risk of surgical treatment. At present, the surgical and endovascular treatment for diseases in the ascending aorta, descending aorta and abdominal aorta are becoming more and more mature. However, due to the complexity of the aortic arch in anatomy, function and pathological changes, the optimal treatment strategy for diseases in the aortic arch has been controversial constantly. This research is a multi-center(four centers), prospective, controlled, large-scale (about 400 subjects) clinical study, using traditional thoracic surgery of aortic arch disease as a control to verify that new techniques for endovascular treatment is not inferior to traditional thoracic surgery in terms of efficiency and safety. Further more, the investigators plan to explore the indications of the application of these new techniques, develop a better diagnosis and treatment program, reduce the risk of such surgical treatment and the incidence of complications, improve clinical efficacy and the overall quality of the disease.

Conditions

Aortic Dissection; Aortic Arch Aneurysm; Ulcer; Pseudoaneurysm

Keywords

Aortic Arch; Endovascular Treatment; Traditional Open Surgery; Chimney Technique; Fenestration Technique; Branched Stent-grafts Technique

Outcome Measures

Primary Outcomes (3)

• No death within 30 days after surgery

  Death from all causes would be included.

  1 month after surgery for treating aortic arch disease performed

• No adverse cardiovascular and cerebrovascular events within one year after surgery

  Cerebrovascular adverse events include global neurological deficit, focal neurological deficit and spinal neurological deficit. Cardiovascular adverse events include extensive myocardial ischemia, low cardiac output syndrome, malignant arrhythmia and massive pericardial effusion.

  12 month after surgery for treating aortic arch disease performed

• No reoperative intervention associated with aorta occurred within one year after surgery

  Reoperative intervention associated with aorta means unintended open or endovascular treatment of the aortic disease, excluding non-aortic surgery.

  12 month after surgery

Secondary Outcomes (10)

• Postoperative leakage

  When patient is discharged from hospital after surgery for treating aortic arch disease performed, 6 month and 12 month after surgery for treating aortic arch disease performed

• Patency rate of aortic arch branches

  When patient is discharged from hospital after surgery for treating aortic arch disease performed, 6 month and 12 month after surgery for treating aortic arch disease performed

• Device-related adverse events occurred

  When patient is discharged from hospital after surgery for treating aortic arch disease performed, 1 month, 6 month and 12 month after surgery for treating aortic arch disease performed

• Postoperative new pulmonary infections

  30 days after surgery for treating aortic arch disease performed.

• Hypostatic pneumonia

  When patient is discharged from hospital after surgery for treating aortic arch disease performed, 1 month, 6 month and 12 month after surgery for treating aortic arch disease performed

Other Outcomes (1)

• Extremities blood pressure measurement

  3 days before the surgery for treating aortic arch disease performed, 5 days after surgery for treating aortic arch disease performed

Study Arms (2)

Endovascular Aortic Repair

Patients with aortic arch lesions who only received endovascular treatment, including chimney / fenestration / branch stent-grafts technique and combination of these techniques, would be assigned to this group.

Procedure: Endovascular Aortic Repair

Total Arch Replacement

Patients with aortic arch lesions who only received traditional open surgery for total aortic arch replacement, would be assigned to this group.

Procedure: Total Arch Replacement

Interventions

Endovascular Aortic Repair PROCEDURE

Without surgery to expose the lesion directly, minimal invasive treatment for the aortic arch lesion under the guidance of imaging equipment is performed through the blood vessel with a tiny wound of a few centimeters, in our research, including chimney, branch stent-grafts and fenestration techniques.

Endovascular Aortic Repair

Total Arch Replacement PROCEDURE

A kind of open surgery is performed for the replacement of total aortic arch.

Total Arch Replacement

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients had aortic arch lesions, need surgery, and are hospitalized in these four hospitals (Fuwai Hospital, Beijing Hospital, China-Japan Friendship Hospital and Peking University People's Hospital) . These four hospitals are all located in Beijing, China.

You may qualify if:

• Patients have aortic arch lesions caused by atherosclerosis and hypertension, and are also suitable for both chimney/ fenestration / branch stent-grafts technique and total arch replacement surgery simultaneously.
• Lesions involve the aortic arch, at least one branch of the aortic arch to be revascularized.
• The type of lesion is dissection, aneurysm, pseudoaneurysm, or ulcer.
• Life expectancy is more than 1 year.
• Patients are able to understand the purpose of this trial, voluntarily attend and sign the informed consent form, and are willing to accept the specified follow-up at specific time point.

You may not qualify if:

• Patients had a stroke or ST-segment elevation myocardial infarction within 30 days prior to surgery.
• Patients underwent major surgery (grade 3 or above) or interventional therapy within 30 days prior to surgery.
• Patients will undergo any major elective surgery (grade 3 or above) or interventional therapy within 30 days after surgery.
• Patients had a previous thoracic aortic surgery in the past.
• Patients had previous thoracic aortic endovascular treatment, and the last implants had an effect on this procedure or had intersections with implants would be used in this procedure.
• Patients need intervention in other vascular lesions (such as coronary arteries, lower extremity arteries, carotid arteries) in the same procedure, or have heart disease and postoperative medication regimens are affected.
• Patients have hepatic and renal insufficiency (serum creatinine\> 186umol / L, Child-Pugh grade B, grade C).
• Aortic arch lesions are not caused by atherosclerosis or hypertension, such as connective tissue disease, aortic genetic diseases, etc.
• Aortic arch lesions are caused by Infectious diseases.
• Patients had serious illnesses (eg, severe chronic obstructive pulmonary disease (COPD) , cancer, dementia, etc.), or the physical condition would affect patients' compliance in this study.
• Patients are currently participating in other studies, and the primary endpoint has not been reached.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Peking University People's Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Beijing Hospital: collaborator

Study Sites (4)

Beijing Hospital

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Chian-Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Dissection; Aneurysm, Aortic Arch; Ulcer; Aneurysm, False

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Aortic Aneurysm, Thoracic; Aortic Aneurysm; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Chang Shu, Director

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyao Luo, Physician

CONTACT

+86 17701022238; luomingyao@hotmail.com

Kun Fang, Physician

CONTACT

+86 15201120100; frankinxy@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vascular Surgery Center

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: November 20, 2017
• Study Start: November 22, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

CN (4)