The purpose of this study is to demonstrate that enhanced vascular healing with the Synergy stent should minimize the risk of late aneurysm formation and potential clinical complications but not at the cost of enhanced efficacy.
Study Type
OBSERVATIONAL
Enrollment
215
Belfast Health & Social Care Trust
Belfast, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, United Kingdom
Golden Jubilee, Glasgow
Glasgow, United Kingdom
The primary stent endpoint is 12-month target vessel failure (TVF) rate
The primary stent endpoint is 12-month target vessel failure (TVF) rate, defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or cardiac death.
Time frame: 12 months
The primary balloon endpoint is device procedural success
Successful delivery of the Emerge Coronary Dilatation catherter across the lesion and Successful inflation and removal of the Emerge Coronary Dilatation catherter with absences of clinically significant vessel perforation or flow limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline, clinically significant arrythmias requiring medical treatment or device intervention following dilatation with Emerge balloon and Achievment of final TIMLI 3 flow for the target lesion at the conclusion of the index procedure. The primary balloon endpoint will be evaluated in patients where an attempt to use an Emerge Coronary Dilatation catherter is made.
Time frame: 1 month
Target lesion revascularization (TLR) rate
Time frame: In hospital, 6 Months, 12 Months, 2 Years
Target lesion failure (TLF) rate
Time frame: In hospital, 6 Months, 12 Months, 2 Years
Target vessel revascularization (TVR) rate
Time frame: In hospital, 6 Months, 12 Months, 2 Years
Target vessel failure (TVF) rate
Time frame: In hospital, 6 Months, 12 Months, 2 Years
Myocardial infarction (MI, Q-wave and non-Q-wave) rate
Time frame: In hospital, 6 Months, 12 Months, 2 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
London Chest Hospital,
London, United Kingdom
Kings College, London
London, United Kingdom
Cardiac death rate
Time frame: In hospital, 6 Months, 12 Months, 2 Years
Non-cardiac death rate
Time frame: In hospital, 6 Months, 12 Months, 2 Years
All death rate
Time frame: In hospital, 6 Months, 12 Months, 2 Years
Cardiac death or MI rate
Time frame: In hospital, 6 Months, 12 Months, 2 Years
All death or MI rate
Time frame: In hospital, 6 Months, 12 Months, 2 Years
All death/MI/TVR rate
Time frame: In hospital, 6 Months, 12 Months, 2 Years
Stent thrombosis rate (by ARC definitions)
Time frame: In hospital, 6 Months, 12 Months, 2 Years
Angina, dyspnoea and quality of life scores
Time frame: 12 Months
In-stent and in-segment percent diameter stenosis (%DS)
Time frame: Peri-procedural
In-stent and in-segment minimum lumen diameter (MLD)
Time frame: Peri-procedural
Acute gain
Time frame: Peri-procedural
In-stent and in-segment %DS
Time frame: 12-Months Post-Index Procedure
In-segment late loss
Time frame: 12-Months Post-Index Procedure
In-stent and in-segment binary restenosis rate
Time frame: 12-Months Post-Index Procedure
In-stent and in-segment MLD
Time frame: 12-Months Post-Index Procedure
Incomplete apposition
Time frame: Peri-procedural
Stent, vessel and lumen areas and volumes
Time frame: Peri-procedural
Incomplete apposition
Time frame: 12-Months Post-Index Procedure
Aneurysm formation
Time frame: 12-Months Post-Index Procedure
Endothelial strut coverage percentage
Time frame: 12-Months Post-Index Procedure