Evaluation of One-stop Strategy of EVAR and PCI

Not Applicable

• Conditions: Coronary Artery Disease; Aortic Atherosclerotic Disease
• Interventions: Procedure: One stop strategy group

• Registration Number: NCT03540342
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-04-11
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-28
• Last Update Submitted: 2018-05-28
• Study First Posted: 2018-05-30
• Last Update Posted: 2018-05-30
• Study Start: 2018-06-30
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One stop strategy group	One stop strategy group	Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)

Primary Outcome Measures

Name	Time	Method
Treatment-Emergent Adverse Events	12 months	The incidence of a composite endpoint of all-cause mortality, myocardial infarction, rupture of aorta, hematoma, bleeding events (BARC≥2 grade), pseudoaneurysm, stent thrombosis

Secondary Outcome Measures

Name	Time	Method
Average cost during hospitalization	12 months
Operative success rate	12 months
Average in-patient time	12 months

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences, Fuwai Hospital; 🇨🇳 Beijing, Beijing, China