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

Stable Angina Clinical Trial

— BVS-Flow  

Official title:

Comparison of the Vasomotor Function and Myocardial Flow in Patients Treated

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738658
• Other study ID #: 20151810
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2015
• Est. completion date: July 2, 2018

Study information

• Verified date: July 2018
• Source: Institut d'Investigació Biomèdica de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 >

Related Conditions & MeSH terms

• Angina, Stable
• Stable Angina

Intervention

Device:
• Bioresorbable vascular scaffold

• Everolimus-eluting stent

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari de Bellvitge	L´Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Bellvitge	Fundació La Marató de TV3

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in fractional flow reserve at maximal hyperemia between the two treatment groups as assessed by pressure-wire measurement		1-year after stent implantation
Primary	Difference in the average peak velocity at maximal hyperemia between bioresorbable vascular scaffolds and everolimus-eluting stents as assessed by doppler wire measurement.		1-year after stent implantation
Secondary	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)		1-year after stent implantation