In-Stent Restenosis
Conditions
Keywords
restenosis, ISR, in-stent restenosis, drug eluting stent, rapamycin eluting stent, paclitaxel eluting balloon catheter
Brief summary
The aim of the study is to compare rapamycin eluting stent and paclitaxel eluting balloon catheter in the treatment of restenosis in bare metal stent.
Detailed description
Study aims: * Clinical efficacy evaluation of different treatment's strategies, including periprocedural and long-term endpoints defined as: death, myocardial infarction, brain stroke, necessity of repeated revascularization * Evaluation of intravascular ultrasound (IVUS) as an optimisation method for direct and long-term revascularization effects * Evaluation of optical coherence tomography as an optimisation method for direct and long-term revascularization effects * Evaluation of late lumen loss and neointimal hyperplasia in stent in long-term follow-up * Analysis of direct and indirect medical costs of alternative treatment strategies Study group: 200 patients with symptomatic restenosis evidenced angiographically in bare metal stent implanted in native coronary artery. Patients will be randomised to 2 therapeutic groups: * Patients treated with rapamycin eluting stent (n=100) * Patients treated with paclitaxel eluting balloon catheter (n=100)
Interventions
DEVICERapamycin eluting stent implantation
Rapamycin eluting stent implantation for in-stent restenosis treatment
Paclitaxel eluting balloon catheter for in-stent restenosis treatment
Sponsors
KCRI
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years of age * symptomatic restenosis in bare metal stent implanted in native coronary artery * angina pectoris * ischemia evidenced by non-invasive diagnostic tests * angiographically evidenced in-stent restenosis \> 50% assessed by quantitative coronary angiography (QCA) * vessel diameter \> 2,5 mm Clinical
Exclusion criteria
* myocardial infarction within less than past 72 hours * heart failure with left ventricular ejection fraction (LVEF) \< 30% * chronic renal failure with significant impairment of glomerular filtration (creatinine \> 2 mg/dl) * hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel, heparin, abciximab, rapamycin, paclitaxel * hypersensitivity to contrast * other diseases that may cause significant deterioration in long-term prognosis * acute or chronic inflammatory diseases * patients who are unwilling to consent for participation in the study Angiographic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of repeated restenosis angiographically evidenced | at 9 months |
| Neointimal volume assessed by intravascular ultrasound (IVUS) | at 9 months |
| Late lumen loss and neointimal volume assessed by optical coherence tomography (OCT) | at 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of myocardial infarction | at 9 months |
| Incidence of repeated target lesion revascularization (TLR) | at 9 months |
| Incidence of in-stent thrombosis | at 9 months |
| Incidence of brain stroke | at 9 months |
| Incidence of repeated target vessel revascularization (TVR) | at 9 months |
| Incidence of death | at 9 months |
Countries
Poland
Outcome results
None listed