Evaluation of One-stop Strategy of EVAR and PCI

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Aortic Atherosclerotic Disease
• Intervention / Treatment: Procedure: One stop strategy group

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Yang, MD; Phone Number: +861088396173; Email: 13810727489@163.com
• Study Contact Backup: Name: Kuo Zhang, MD; Phone Number: +8618813019602; Email: kzhang23@outlook.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Chinese Academy of Medical Sciences, Fuwai Hospital
      • Contact: Min Yang, MD; Phone Number: +861088396173; Email: 13810727489@163.com
      • Contact: Kuo Zhang, MD; Phone Number: +8618813019602; Email: kzhang23@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Staging strategy group; PCI will be performed several days after EVAR
Experimental: One stop strategy group; Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)	Procedure: One stop strategy group; Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative success rate	12 months
Average in-patient time	12 months
Average cost during hospitalization	12 months

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: May 28, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; coronary artery disease; endovascular aortic repair; aortic atherosclerotic disease; one-stop
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: Z171100000417021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No