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Coronary Microcirculatory and Bioresorbable Vascular Scaffolds (EMPIRE-BVS)

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ClinicalTrials.gov Identifier: NCT03076476
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
CHD - Coronary Heart Disease Angina, Stable Myocardial Ischemia Device: Bioresorbable Vascular Scaffolds (BVS) Device: Drug-Eluting Stent (DES) - slow Device: Drug-Eluting Stent (DES) - standard(std) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: DES-std group
(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.
Device: 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.
Other Name: Xience

Experimental: DES-slow group

(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.

Device: 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.

Other Name: Xience

Experimental: BVS group
(Bioresorbable Vascular Scaffold) Introduced after the interim analysis (phase 2) for comparison with DES-slow.
Device: Bioresorbable Vascular Scaffolds (BVS)
Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.
Other Name: ABSORB




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076476


Contacts
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Contact: Stephen Hoole 01480 366172 ext 6172 s.hoole@nhs.net
Contact: Tian Zhao 01480 364475 ext 4475 tian.zhao@nhs.net

Locations
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United Kingdom
Papworth Hospital NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Contact: Kitty Paques    01480 830541 ext 4594    kitty.paques@nhs.net   
Contact: Melissa Duckworth    01480 364451 ext 451    melissa.duckworth@nhs.net   
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
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Study Director: Melissa Duckworth Papworth NHS Foundation Trust

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Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03076476     History of Changes
Other Study ID Numbers: P02135
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Papworth Hospital NHS Foundation Trust:
Coronary Stent
PCI
BVS
Index of microcirculatory resistance
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina, Stable
Ischemia
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms