Back to resultsEvaluation of One-stop Strategy of EVAR and PCI
Primary Purpose
Coronary Artery Disease, Aortic Atherosclerotic Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
One stop strategy group
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, aortic atherosclerotic disease, one-stop, percutaneous coronary intervention, endovascular aortic repair
Eligibility Criteria
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
Sites / Locations
- Chinese Academy of Medical Sciences, Fuwai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
One stop strategy group
Staging strategy group
Arm Description
Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)
PCI will be performed several days after EVAR
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Operative success rate
Average in-patient time
Average cost during hospitalization
Full Information
NCT ID
NCT03540342
First Posted
April 11, 2018
Last Updated
May 28, 2018
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03540342
Brief Title
Evaluation of One-stop Strategy of EVAR and PCI
Official Title
Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2018 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Aortic Atherosclerotic Disease
Keywords
coronary artery disease, aortic atherosclerotic disease, one-stop, percutaneous coronary intervention, endovascular aortic repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
One stop strategy group
Arm Type
Experimental
Arm Description
Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)
Arm Title
Staging strategy group
Arm Type
No Intervention
Arm Description
PCI will be performed several days after EVAR
Intervention Type
Procedure
Intervention Name(s)
One stop strategy group
Intervention Description
Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)
Primary Outcome Measure Information:
Title
Treatment-Emergent Adverse Events
Description
The incidence of a composite endpoint of all-cause mortality, myocardial infarction, rupture of aorta, hematoma, bleeding events (BARC≥2 grade), pseudoaneurysm, stent thrombosis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Operative success rate
Time Frame
12 months
Title
Average in-patient time
Time Frame
12 months
Title
Average cost during hospitalization
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Yang, MD
Phone
+861088396173
Email
13810727489@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kuo Zhang, MD
Phone
+8618813019602
Email
kzhang23@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Da Tang, MD, PhD
Organizational Affiliation
Chinese Academy of Medical Sciences, Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences, Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yang, MD
Phone
+861088396173
Email
13810727489@163.com
First Name & Middle Initial & Last Name & Degree
Kuo Zhang, MD
Phone
+8618813019602
Email
kzhang23@outlook.com
12. IPD Sharing Statement
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Evaluation of One-stop Strategy of EVAR and PCI
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