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CHD - Coronary Heart DiseaseEMPIRE-BVSNCT03076476

Coronary Microcirculatory and Bioresorbable Vascular Scaffolds

A study testing Bioresorbable Vascular Scaffolds (BVS), Drug-Eluting Stent (DES) - slow and Drug-Eluting Stent (DES) - standard(std) in people with CHD - Coronary Heart Disease and Angina, Stable, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Bioresorbable Vascular Scaffolds (BVS), Drug-Eluting Stent (DES) - slow and Drug-Eluting Stent (DES) - standard(std)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited Kingdom
Study dates
1 Feb 2017to 10 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%).

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Papworth Hospital NHS Foundation Trust

    Cambridge, Cambridgeshire, CB23 3RE

Other trials in United Kingdom

About this study

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

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.

Being tested
Bioresorbable Vascular Scaffolds (BVS), Drug-Eluting Stent (DES) - slow, Drug-Eluting Stent (DES) - standard(std)
Keywords
Coronary Stent, PCI, BVS, Index of microcirculatory resistance
Medical subject headings
Coronary Artery Disease, Angina, Stable, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioresorbable Vascular Scaffolds (BVS)Device

    Also called ABSORB

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

  • Drug-Eluting Stent (DES) - slowDevice

    Also called Xience

    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.

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

    Also called Xience

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

Study groups in NCT03076476
Study groupRoleWhat they receive
DES-std groupActive comparator(DES: drug-eluting stent). Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.
Receives: Device: Drug-Eluting Stent (DES) - standard(std)
DES-slow groupExperimental(DES: drug-eluting stent). 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.
Receives: Device: Drug-Eluting Stent (DES) - slow
BVS groupExperimental(Bioresorbable Vascular Scaffold) Introduced after the interim analysis (phase 2) for comparison with DES-slow.
Receives: Device: Bioresorbable Vascular Scaffolds (BVS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    IMR: index of microvascular resistance

    Measured: During procedure

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

    CFR: coronary flow reserve

    Measured: During procedure

Secondary outcomes (8)

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

    Measuring serum troponin I levels by blood test

    Measured: Measured 6 hours after stent insertion

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

    IMR: index of microvascular resistance

    Measured: 3 months follow up

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

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

    Measured: Up to 12 months

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

    OCT analysis of stent struts done quantitatively

    Measured: During index procedure and at 3 month follow up

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

    OCT analysis of stent struts done quantitatively

    Measured: During index procedure and at 3 month follow up

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

    OCT analysis of lesion characteristics done quantitatively

    Measured: During index procedure and at 3 month follow up

  7. Adverse events

    Adverse event assessed by clinical history and medical notes

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

  8. Serious adverse events

    Serious adverse event assessed by clinical history and medical notes

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2017
  2. Study start1 Feb 2017
  3. Primary completion10 Mar 2021
  4. Study completion10 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03076476
Sponsor's protocol ID
P02135
Acronym
EMPIRE-BVS
Status last verified
Apr 2022
First submitted
26 Jan 2017
Last updated
22 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aetesam-Ur-Rahman M, Zhao TX, Paques K, Oliveira J, Chiu YD, Duckworth M, Khialani B, Kyranis S, Bennett MR, West NEJ, Hoole SP. Evaluation of microcirculatory protection in percutaneous revascularisation: A stent implantation technique and device comparison. Catheter Cardiovasc Interv. 2024 Sep;104(3):462-471. doi: 10.1002/ccd.31155. Epub 2024 Jul 24.

    PubMed 39044651

  • Aetesam-Ur-Rahman M, Zhao TX, Paques K, Oliveira J, Khialani B, Kyranis S, Braganza DM, Clarke SC, Bennett MR, West NEJ, Hoole SP. Coronary Flow Variations Following Percutaneous Coronary Intervention Affect Diastolic Nonhyperemic Pressure Ratios More Than the Whole Cycle Ratios. J Am Heart Assoc. 2022 May 3;11(9):e023554. doi: 10.1161/JAHA.121.023554. Epub 2022 Apr 26.

    PubMed 35470686

Questions about this trial

What is this clinical trial studying?

A study testing Bioresorbable Vascular Scaffolds (BVS), Drug-Eluting Stent (DES) - slow and Drug-Eluting Stent (DES) - standard(std) in people with CHD - Coronary Heart Disease and Angina, Stable, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in IMR between baseline and post-stent/scaffold implantation. (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03076476, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.

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