Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA)

Study Overview
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Brief Summary
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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
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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)

Official Title
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Efficacy Evaluation of In-bare Metal Stent Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter. Study With Intravascular Ultrasound and Optical Coherence Tomography

Conditions
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In-Stent Restenosis

Intervention / Treatment
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* Device: Rapamycin eluting stent implantation
* Device: Paclitaxel eluting balloon catheter


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria: significant stenosis in left main coronary artery (LM) multivessel disease qualifying for coronary artery bypass grafting (CABG) anatomical localization and morphology that preclude optimal percutaneous intervention intervention's (PCI) result or intravascular ultrasound (IVUS) or optical coherence tomography performance vessel diameter < 2,5 mm restenotic lesion length > 30 mm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapamycin eluting stent<br>Patients treated with rapamycin eluting stent (n=100) | Device: Rapamycin eluting stent implantation<br>* Rapamycin eluting stent implantation for in-stent restenosis treatment<br>|
| Experimental: Paclitaxel eluting balloon catheter<br>Patients treated with paclitaxel eluting balloon catheter (n=100) | Device: Paclitaxel eluting balloon catheter<br>* Paclitaxel eluting balloon catheter for in-stent restenosis treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of repeated target lesion revascularization (TLR) |  | at 9 months | 
| Incidence of repeated target vessel revascularization (TVR) |  | at 9 months | 
| Incidence of death |  | at 9 months | 
| Incidence of myocardial infarction |  | at 9 months | 
| Incidence of brain stroke |  | at 9 months | 
| Incidence of in-stent thrombosis |  | at 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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restenosis, ISR, in-stent restenosis, drug eluting stent, rapamycin eluting stent, paclitaxel eluting balloon catheter