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

NCT ID: NCT03563768

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Aortic Atherosclerotic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One-stop strategy group

Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)

Group Type EXPERIMENTAL

One-stop strategy group

Intervention Type PROCEDURE

Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)

Staging strategy group

PCI will be performed several days after EVAR

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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One-stop strategy group

Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi-Da Tang

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi-Da Tang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Min Yang, MD

Role: CONTACT

00861088396173

Kuo Zhang, MD, PhD

Role: CONTACT

008618813019602

Other Identifiers

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2018-2-4032

Identifier Type: -

Identifier Source: org_study_id

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