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Coronary Microcirculatory and Bioresorbable Vascular Scaffolds (EMPIRE-BVS)

Primary Purpose

CHD - Coronary Heart Disease, Angina, Stable, Myocardial Ischemia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bioresorbable Vascular Scaffolds (BVS)
Drug-Eluting Stent (DES) - slow
Drug-Eluting Stent (DES) - standard(std)
Sponsored by
Papworth Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CHD - Coronary Heart Disease focused on measuring Coronary Stent, PCI, BVS, Index of microcirculatory resistance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Papworth Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

DES-std group

DES-slow group

BVS group

Arm Description

(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.

(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.

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

Outcomes

Primary Outcome Measures

Change in IMR between baseline and post-stent/scaffold implantation.
IMR: index of microvascular resistance
Change in CFR between baseline and post-stent/scaffold implantation.
CFR: coronary flow reserve

Secondary Outcome Measures

Incidence of troponin elevation post-PCI (MI4a).
Measuring serum troponin I levels by blood test
Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group.
IMR: index of microvascular resistance
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
Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis.
OCT analysis of stent struts done quantitatively
Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis.
OCT analysis of stent struts done quantitatively
Nature/phenotype of underlying target lesion plaque by OCT analysis.
OCT analysis of lesion characteristics done quantitatively
Adverse events
Adverse event assessed by clinical history and medical notes
Serious adverse events
Serious adverse event assessed by clinical history and medical notes

Full Information

First Posted
January 26, 2017
Last Updated
April 21, 2022
Sponsor
Papworth Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03076476
Brief Title
Coronary Microcirculatory and Bioresorbable Vascular Scaffolds
Acronym
EMPIRE-BVS
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Papworth Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHD - Coronary Heart Disease, Angina, Stable, Myocardial Ischemia
Keywords
Coronary Stent, PCI, BVS, Index of microcirculatory resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DES-std group
Arm Type
Active Comparator
Arm Description
(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.
Arm Title
DES-slow group
Arm Type
Experimental
Arm Description
(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.
Arm Title
BVS group
Arm Type
Experimental
Arm Description
(Bioresorbable Vascular Scaffold) Introduced after the interim analysis (phase 2) for comparison with DES-slow.
Intervention Type
Device
Intervention Name(s)
Bioresorbable Vascular Scaffolds (BVS)
Other Intervention Name(s)
ABSORB
Intervention Description
Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.
Intervention Type
Device
Intervention Name(s)
Drug-Eluting Stent (DES) - slow
Other Intervention Name(s)
Xience
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Drug-Eluting Stent (DES) - standard(std)
Other Intervention Name(s)
Xience
Intervention Description
Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.
Primary Outcome Measure Information:
Title
Change in IMR between baseline and post-stent/scaffold implantation.
Description
IMR: index of microvascular resistance
Time Frame
During procedure
Title
Change in CFR between baseline and post-stent/scaffold implantation.
Description
CFR: coronary flow reserve
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Incidence of troponin elevation post-PCI (MI4a).
Description
Measuring serum troponin I levels by blood test
Time Frame
Measured 6 hours after stent insertion
Title
Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group.
Description
IMR: index of microvascular resistance
Time Frame
3 months follow up
Title
Incidence of post-PCI angina and quality of life by standardized Seattle angina questionnaire at telephone follow-up.
Description
Description: The Seattle Angina Questionnaire is a points based question and answer system where a overall score can be assessed and compared
Time Frame
Up to 12 months
Title
Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis.
Description
OCT analysis of stent struts done quantitatively
Time Frame
During index procedure and at 3 month follow up
Title
Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis.
Description
OCT analysis of stent struts done quantitatively
Time Frame
During index procedure and at 3 month follow up
Title
Nature/phenotype of underlying target lesion plaque by OCT analysis.
Description
OCT analysis of lesion characteristics done quantitatively
Time Frame
During index procedure and at 3 month follow up
Title
Adverse events
Description
Adverse event assessed by clinical history and medical notes
Time Frame
At time points 1, 3, 6 & 12 months post-PCI
Title
Serious adverse events
Description
Serious adverse event assessed by clinical history and medical notes
Time Frame
At time points 1, 3, 6 & 12 months post-PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Duckworth
Organizational Affiliation
Papworth NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Papworth Hospital NHS Foundation Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35470686
Citation
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.
Results Reference
derived

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Coronary Microcirculatory and Bioresorbable Vascular Scaffolds

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