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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with 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.
Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Change in IMR between baseline and post-stent/scaffold implantation.
IMR: index of microvascular resistance
Time frame: During procedure
Change in CFR between baseline and post-stent/scaffold implantation.
CFR: coronary flow reserve
Time frame: During procedure
Incidence of troponin elevation post-PCI (MI4a).
Measuring serum troponin I levels by blood test
Time frame: Measured 6 hours after stent insertion
Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group.
IMR: index of microvascular resistance
Time frame: 3 months follow up
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
Time frame: Up to 12 months
Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis.
OCT analysis of stent struts done quantitatively
Time frame: During index procedure and at 3 month follow up
Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis.
OCT analysis of stent struts done quantitatively
Time frame: During index procedure and at 3 month follow up
Nature/phenotype of underlying target lesion plaque by OCT analysis.
OCT analysis of lesion characteristics done quantitatively
Time frame: During index procedure and at 3 month follow up
Adverse events
Adverse event assessed by clinical history and medical notes
Time frame: At time points 1, 3, 6 & 12 months post-PCI
Serious adverse events
Serious adverse event assessed by clinical history and medical notes
Time frame: At time points 1, 3, 6 & 12 months post-PCI
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.