Comparison of the Vasomotor Function and Myocardial Flow in Patients Treated With Bioresorbable and Metallic Stents at 1 Year

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2018-07-02

Brief Summary

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Background: A total of 25-50% of patients with stable coronary atherosclerosis treated with metallic stent implantation remain with effort angina despite optimal medical treatment and absence of stent restenosis at 1 year. The most plausible cause of persistent effort angina after stent implantation is microcirculatory dysfunction. Coronary circulation matches the myocardial blood supply and oxygen consumption. Metallic stent implantation has been related with endothelial dysfunction and impaired coronary blood flow reserve (relation between coronary blood flow at rest and maximal hyperemia) of the treated vessel at 1 year.

Bioresorbable Vascular Scaffold (BVS) has been shown to improve the endothelial function and to improve the angina symptoms at 1 year. However, the coronary blood flow of BVS has never been tested.

Main objective: To determine differences in the blood average peak velocity at maximal hyperemia with adenosine infusion between patients treated with bioresorbable and metallic coronary stents at 1 year after stent implantation.

Methodology: A total of 70 patients are 1:1 randomized to everolimus-eluting metallic stent (EES) versus everolimus-eluting BVS implantation in patients with stable coronary disease. At 1 year, patients undergo to invasive coronary angiography prior cessation of vasomotor drugs. A pressure/Doppler wire is advanced distally to the "treated segment" and the endothelial (acetylcholine) and non-endothelial (adenosine and nitroglycerine) vasomotor function is assessed with quantitative coronary angiography and pressure and Doppler measurements. Angina test questionnaires are obtained at different time-points of the study.

Expected results: A difference between patients treated with BVS and EES of 12.0 cm/sc in the maximal average peak velocity (APV) under maximal hyperemia (with adenosine administration) is expected, as assessed by Doppler measurements, at 1 year after stent implantation. The study is powered to assess superiority in terms of maximal APV favoring patients treated with BVS.

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Detailed Description

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Conditions

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Stable Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Bioresorbable vascular scaffold (BVS)

Patients with stable coronary angina with coronary artery disease suitable to be treated with a bioresorbable vascular scaffold.

Group Type EXPERIMENTAL

Bioresorbable vascular scaffold

Intervention Type DEVICE

Everolimus-eluting stent (EES)

Patients with stable coronary angina with coronary artery disease suitable to be treated with a Everolimus-eluting stent .

Group Type ACTIVE_COMPARATOR

Everolimus-eluting stent

Intervention Type DEVICE

Interventions

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Bioresorbable vascular scaffold

Intervention Type DEVICE

Everolimus-eluting stent

Intervention Type DEVICE

Other Intervention Names

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Bioresorbable stents

Eligibility Criteria

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Inclusion Criteria

* Patients with stable angina or silent angina with myocardial ischemia detected by non-invasive tests or patients with acute coronary syndromes with no increase of \> 5 times the upper value of normality of cardiac biomarkers (troponin).
* Patients with coronary artery disease with angiographic stenosis \>

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No