Evaluation of One-stop Strategy of EVAR and PCI

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Unknown

Conditions: Coronary Artery Disease; Aortic Atherosclerotic Disease

Treatments: Procedure: One stop strategy group

Study type: Interventional

Funder types: Other

Identifiers

NCT03540342

Z171100000417021

Details and patient eligibility

About

The study is designed to evaluate the safety and effectiveness of the "one-stop" endovascular intervention strategy for patients with concomitant coronary artery disease and aortic atherosclerotic disease. It is a registration study, which will consecutively enroll at least 50 patients with at least 30 subjects receiving one-stop strategy.

Full description

It is a registration study, at least 50 patients will be consecutively enrolled and then be allocated into one-stop strategy group or staging strategy group with at least 30 subjects receiving one-stop strategy. In one stop strategy group, percutaneous coronary intervention (PCI) will be performed on the same operating table 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 the two groups untill 1 year after the operation. The economic index will be evaluated.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged from 18 years to 75years, male or female;
• Aortic atherosclerotic disease with the indication of EVAR;
• Coronary heart disease with the 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: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 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