Coronary Microcirculatory and Bioresorbable Vascular Scaffolds

Myocardial Ischemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076476
• Other study ID #: P02135
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: March 10, 2021

Study information

• Verified date: April 2022
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina, Stable
• CHD - Coronary Heart Disease
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• Bioresorbable Vascular Scaffolds (BVS)
Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.
• Drug-Eluting Stent (DES) - slow
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)
Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital NHS Foundation Trust	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IMR between baseline and post-stent/scaffold implantation.	IMR: index of microvascular resistance	During procedure
Primary	Change in CFR between baseline and post-stent/scaffold implantation.	CFR: coronary flow reserve	During procedure
Secondary	Incidence of troponin elevation post-PCI (MI4a).	Measuring serum troponin I levels by blood test	Measured 6 hours after stent insertion
Secondary	Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group.	IMR: index of microvascular resistance	3 months follow up
Secondary	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	Up to 12 months
Secondary	Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis.	OCT analysis of stent struts done quantitatively	During index procedure and at 3 month follow up
Secondary	Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis.	OCT analysis of stent struts done quantitatively	During index procedure and at 3 month follow up
Secondary	Nature/phenotype of underlying target lesion plaque by OCT analysis.	OCT analysis of lesion characteristics done quantitatively	During index procedure and at 3 month follow up
Secondary	Adverse events	Adverse event assessed by clinical history and medical notes	At time points 1, 3, 6 & 12 months post-PCI
Secondary	Serious adverse events	Serious adverse event assessed by clinical history and medical notes	At time points 1, 3, 6 & 12 months post-PCI