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

Primary Purpose

Coronary Artery Disease, Aortic Atherosclerotic Disease

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

One-stop strategy group

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, aortic atherosclerotic disease, one-stop, endovascular aortic repair, percutaneous coronary intervention

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Perioperative major bleeding (BARC≥3 grade)

Secondary Outcome Measures

Difference of operative success rate between two groups

Difference of incidence of all-cause death between two groups

Difference of incidence of myocardial infarction between two groups

Difference of incidence of rupture of aorta between two groups

Difference of incidence of bleeding events (BARC 2 grade) between two groups

Difference of incidence of pseudoaneurysm between two groups

Difference of incidence of Stent thrombosis between two groups

Composite of average in-patient time and average cost during hospitalization

Full Information

NCT ID

NCT03563768

First Posted

June 10, 2018

Last Updated

June 10, 2018

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03563768

Brief Title

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

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

June 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed 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.

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, endovascular aortic repair, percutaneous coronary intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (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

Perioperative major bleeding (BARC≥3 grade)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Difference of operative success rate between two groups

Time Frame

12 months

Title

Difference of incidence of all-cause death between two groups

Time Frame

12 months

Title

Difference of incidence of myocardial infarction between two groups

Time Frame

12 months

Title

Difference of incidence of rupture of aorta between two groups

Time Frame

12 months

Title

Difference of incidence of bleeding events (BARC 2 grade) between two groups

Time Frame

12 months

Title

Difference of incidence of pseudoaneurysm between two groups

Time Frame

12 months

Title

Difference of incidence of Stent thrombosis between two groups

Time Frame

12 months

Title

Composite of average in-patient time and average cost during hospitalization

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Min Yang, MD

Phone

00861088396173

13810727489@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kuo Zhang, MD, PhD

Phone

008618813019602

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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