Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03563768
• Other study ID #: 2018-2-4032
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 30, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Min Yang, MD
• Phone: 00861088396173
• Email: 13810727489[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a prospective, randomized, controlled, exploratory trail to evaluate the strategy of "one-stop" endovascular treatment for concomitant coronary artery disease and aortic atherosclerotic disease.

Description:

60 patients will be allocated randomly in a 1:1 ratio into one-stop strategy group or staging strategy group. In one-stop strategy group, percutaneous coronary intervention (PCI) will be performed on the same operating room immediately after the endovascular aortic repair (EVAR); In staging strategy group, PCI will be performed several days after EVAR. The safety and effectiveness will be assessed between two groups 1 year after the operation. The economic index will be evaluated as well as.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Aged from 18 years to 75years, male or female;

• Aortic atherosclerotic disease with indication of EVAR;

• Coronary heart disease with indication of PCI;

• Provided informed consent.

Exclusion Criteria:

• Acute aortic dissection

• Acute coronary syndrome

• Dysfunction of coagulation system

• Patients with gastrointestinal hemorrhage

• Known allergy to contrasts or antiplatelet drugs

• Renal dysfunction (GFR=60ml/min)

• Patient with multi-branch coronary preferred CABG

Related Conditions & MeSH terms

• Aortic Atherosclerotic Disease
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• One-stop strategy group
Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative major bleeding (BARC=3 grade)		12 months
Secondary	Difference of operative success rate between two groups		12 months
Secondary	Difference of incidence of all-cause death between two groups		12 months
Secondary	Difference of incidence of myocardial infarction between two groups		12 months
Secondary	Difference of incidence of rupture of aorta between two groups		12 months
Secondary	Difference of incidence of bleeding events (BARC 2 grade) between two groups		12 months
Secondary	Difference of incidence of pseudoaneurysm between two groups		12 months
Secondary	Difference of incidence of Stent thrombosis between two groups		12 months
Secondary	Composite of average in-patient time and average cost during hospitalization		12 months