Coronary Stent Restenosis
Conditions
Keywords
drug eluting stent, restenosis, drug coated balloon
Brief summary
The aim of this open label, randomized study is to compare the safety and efficacy of three different methods to handle coronary drug eluting stent (DES) in-stent restenosis (ISR). These are the: * Magic Touch - sirolimus coated balloon * Emperor - paclitaxel and dextran coated balloon * Xience - chromium-cobalt everolimus eluting stent
Interventions
PROCEDUREIntravascular management of prior implanted coronary drug eluting stent restenosis
Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.
Sponsors
Semmelweis University Heart and Vascular Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients admitted for intervention of drug eluting stent restenosis * Restenosis suitable for all three treatment arms as per 'instructions for use' of the devices * Optional enrollment in the optical coherence tomography sub-study (10-20% of patients)
Exclusion criteria
* Patients undergoing coronary angiography after sudden cardiac death * Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of new onset target vessel myocardial infarction | 6 months | New onset myocardial infarction that affects the target vessel treated with either study device |
| Occurrence of target vessel revascularization of failure | 6 months | The need for further revascularization affecting the target vessel treated with either study device, or the failure of the vessel treated by either study device. |
| Occurrence of target lesion revascularization | 6 months | The need for further revascularization of the target lesion after treatment with either study device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage late lumen loss | 6 months | Late lumen loss measured via qualitative coronary angiography in treated segment(s) |
| Percentage intraluminal gain after treatment | index procedure | Intraluminal gain after assigned treatment measured via optical coherence tomography |
| Square millimetre intraluminal gain after treatment | index procedure | Intraluminal gain after assigned treatment measured via optical coherence tomography |
| Square millimeter intraluminal gain after treatment | 6 months | Intraluminal gain after assigned treatment measured via optical coherence tomography |
| Endothelium coverage in micrometers | 6 months | Mean endothelium thickness of stent struts in micrometres measured via optical coherence tomography |
| Late lumen loss in square millimetres | 6 months | Late lumen loss in square millimetres measured via optical coherence tomography |
Countries
Hungary
Contacts
PRINCIPAL_INVESTIGATORIstván F Édes, MD PhD
Semmelweis University Heart and Vascular Center
Outcome results
None listed