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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03076476
Other study ID # P02135
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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