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Completed

NCT Number: NCT02738658

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

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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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 >

Treatment and study plan

Bioresorbable vascular scaffold

Device

Other names: Bioresorbable stents

everolimus-eluting stent

Device

Primary outcomes

  1. Difference in the average peak velocity at maximal hyperemia between bioresorbable vascular scaffolds and everolimus-eluting stents as assessed by doppler wire measurement.

    Time frame: 1-year after stent implantation

Secondary outcomes

  1. Difference in endothelial dysfunction with acetyl-choline infusion between bioresorbable vascular scaffolds and everolimus-eluting stents as assessed by quantitative coronary angiography (4% of lumen reduction)

    Time frame: 1-year after stent implantation

Other outcomes

  1. Difference in fractional flow reserve at maximal hyperemia between the two treatment groups as assessed by pressure-wire measurement

    Time frame: 1-year after stent implantation

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Bellvitge

Other

Collaborators

  • Fundació La Marató de TV3

Registry information

Official study title

Comparison of the Vasomotor Function and Myocardial Flow in Patients Treated

Acronym: BVS-Flow

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2016
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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