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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease; Aortic Atherosclerotic Disease

Treatments: Procedure: One-stop strategy group

Study type: Interventional

Funder types: Other

Identifiers

NCT03563768

2018-2-4032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

One-stop strategy group

Experimental group

Description:

Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)

Treatment:

Procedure: One-stop strategy group

Staging strategy group

No Intervention group

Description:

PCI will be performed several days after EVAR