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NCT03076476: EMPIRE-BVS

Coronary Microcirculatory and Bioresorbable Vascular Scaffolds

Completed NA Last updated 22 April 2022
What this trial tests

NA trial testing Bioresorbable Vascular Scaffolds (BVS) in CHD - Coronary Heart Disease in 36 participants. Completed in 10 March 2021.

Timeline
1 February 2017
Primary endpoint
10 March 2021
10 March 2021

Quick facts

Lead sponsorPapworth Hospital NHS Foundation Trust
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment36
Start date1 February 2017
Primary completion10 March 2021
Estimated completion10 March 2021
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Papworth Hospital NHS Foundation Trust

Who can join

Adults 18 to 75, any sex, with CHD - Coronary Heart Disease or Angina, Stable. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels) supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty). Traditionally, stents are constructed from metal and are permanent. However, newer stents are being constructed from carbohydrate polymers (scaffolds), which allow them to reabsorb over time leaving no permanent implant. New data has suggested that these scaffolds appear to reduce recurrent angina and may alter the blood flow down the artery. However, it is not known whether this is due to the scaffolds themselves or the way the scaffolds are inserted. In this study we hope to measure the blood flow to the heart and assess changes in that flow during stent and scaffold insertion. It is also important to know whether these effects are durable and thus, a cohort of patients will return at 3-months to be restudied. These data are important to help us understand why blood flow is affected by stent/scaffold selection or device implantation technique and whether this results in better long-term outcomes.

Publications & conference data

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

  1. Coronary Flow Variations Following Percutaneous Coronary Intervention Affect Diastolic Nonhyperemic Pressure Ratios More Than the Whole Cycle Ratios.
    Aetesam-Ur-Rahman M, Zhao TX, Paques K, Oliveira J, et al · · 2022 · cited 3× · PMID 35470686 · DOI 10.1161/jaha.121.023554

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