Evaluation of One-stop Strategy of EVAR and PCI

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

NA

Total Enrollment

50 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 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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Aortic Atherosclerotic Disease

Study Design

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Allocation Method

NON_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 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No