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Completed

NCT Number: NCT03076476

Coronary Microcirculatory and Bioresorbable Vascular Scaffolds

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.

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Key information

Conditions

CHD - Coronary Heart Disease Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient age >18 years, <75 years.
  • Lesion suitability for BVS deployment: target vessel calibre >2.3mm and <3.8mm reference diameter, without significant tortuosity or calcification.
  • Listed for single-vessel PCI procedure.
  • Lesion length≤28mm (to accommodate single BVS/DES)
  • Preserved left ventricular ejection fraction (EF≥50%).

Exclusion criteria

  • Patients with confirmed myocardial infarction within the preceding 2 months.
  • Allergy or intolerance to aspirin, clopidogrel, prasugrel or ticagrelor or contraindication to 12 months' dual antiplatelet therapy.
  • Contraindication to use of adenosine (asthma/chronic lung disease with documented bronchoreactivity).
  • Significant known comorbidity or terminal condition with life expectancy <6 months.
  • Pregnancy.
  • Coagulopathy or warfarin treatment.
  • Significant renal impairment (baseline creatinine>130 mmol/l).
  • Other comorbid condition that may affect microcirculatory function or troponin release (eg. Seropositive inflammatory conditions).
  • Inability to comply with follow-up requirements.
  • Target lesion in left mainstem, saphenous vein or arterial grafts.
  • Chronic total occlusion.

Treatment and study plan

Bioresorbable Vascular Scaffolds (BVS)

Device

Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.

Other names: ABSORB

Drug-Eluting Stent (DES) - slow

Device

Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage.

After the interim analysis DES-slow to be compared with BVS.

Other names: Xience

Drug-Eluting Stent (DES) - standard(std)

Device

Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.

Other names: Xience

Primary outcomes

  1. Change in IMR between baseline and post-stent/scaffold implantation.

    Time frame: During procedure

    IMR: index of microvascular resistance

  2. Change in CFR between baseline and post-stent/scaffold implantation.

    Time frame: During procedure

    CFR: coronary flow reserve

Secondary outcomes

  1. Incidence of troponin elevation post-PCI (MI4a).

    Time frame: Measured 6 hours after stent insertion

    Measuring serum troponin I levels by blood test

  2. Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group.

    Time frame: 3 months follow up

    IMR: index of microvascular resistance

  3. Incidence of post-PCI angina and quality of life by standardized Seattle angina questionnaire at telephone follow-up.

    Time frame: Up to 12 months

    Description: The Seattle Angina Questionnaire is a points based question and answer system where a overall score can be assessed and compared

  4. Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis.

    Time frame: During index procedure and at 3 month follow up

    OCT analysis of stent struts done quantitatively

  5. Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis.

    Time frame: During index procedure and at 3 month follow up

    OCT analysis of stent struts done quantitatively

  6. Nature/phenotype of underlying target lesion plaque by OCT analysis.

    Time frame: During index procedure and at 3 month follow up

    OCT analysis of lesion characteristics done quantitatively

  7. Adverse events

    Time frame: At time points 1, 3, 6 & 12 months post-PCI

    Adverse event assessed by clinical history and medical notes

  8. Serious adverse events

    Time frame: At time points 1, 3, 6 & 12 months post-PCI

    Serious adverse event assessed by clinical history and medical notes

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Registry information

Official study title

Evaluation of Microcirculatory Protection In Percutaneous REvascularisation With Bioresorbable Vascular Scaffolds Versus Metallic Drug-eluting Stents: a Device- and Implant Technique-based Comparison

Acronym: EMPIRE-BVS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2017
Registry last updated
Apr 22, 2022

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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