NCT02738658: BVS-Flow

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

Completed Phase 4 Last updated 3 July 2018

What this trial tests

Phase 4 trial testing Bioresorbable vascular scaffold in Stable Angina in 70 participants. Completed in 2 July 2018.

Timeline

1 March 2015

Primary endpoint
2 July 2018

2 July 2018

Quick facts

Lead sponsor	Institut d'Investigació Biomèdica de Bellvitge
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	70
Start date	1 March 2015
Primary completion	2 July 2018
Estimated completion	2 July 2018
Sites	3 locations across Spain

Drugs / interventions tested

• Bioresorbable vascular scaffold
• Everolimus-eluting stent

Conditions studied

• Stable Angina — all drugs for Stable Angina →

Sponsor

Institut d'Investigació Biomèdica de Bellvitge — full company profile →

Who can join

18 and older, any sex, with Stable Angina. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Rethinking Endothelial Dysfunction as a Crucial Target in Fighting Heart Failure.
   Premer C, Kanelidis AJ, Hare JM, Schulman IH. · · 2019 · cited 78× · PMID 30899903 · DOI 10.1016/j.mayocpiqo.2018.12.006