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

Medical University of Warsaw

Status and phase

Unknown

Phase 3

Conditions

In-Stent Restenosis

Treatments

Device: Rapamycin eluting stent implantation

Device: Paclitaxel eluting balloon catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT01255956

Restenoza II 4.0

Details and patient eligibility

About

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.

Full 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)

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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