Clinical trial NCT01255956: Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: In-Stent Restenosis
Keywords: restenosis
ISR
in-stent restenosis
drug eluting stent
rapamycin eluting stent
paclitaxel eluting balloon catheter
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: KCRI
First posted: 2010-12-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: Incidence of repeated restenosis angiographically evidenced
timeFrame: at 9 months
measure: Neointimal volume assessed by intravascular ultrasound (IVUS)
timeFrame: at 9 months
measure: Late lumen loss and neointimal volume assessed by optical coherence tomography (OCT)
timeFrame: at 9 months
Secondary outcomes:
measure: Incidence of repeated target lesion revascularization (TLR)
timeFrame: at 9 months
measure: Incidence of repeated target vessel revascularization (TVR)
timeFrame: at 9 months
measure: Incidence of death
timeFrame: at 9 months
measure: Incidence of myocardial infarction
timeFrame: at 9 months
measure: Incidence of brain stroke
timeFrame: at 9 months
measure: Incidence of in-stent thrombosis
timeFrame: at 9 months
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Instytut Kardiologii w Warszawie-Aninie
state: Alpejska 42
city: Warszawa
country: Poland
facility: Katedra i Klinika Kardiologii Warszawskiego Uniwersytetu Medycznego
state: Banacha 1a
city: Lodz
country: Poland
facility: Klinika Kardiologii z Kliniką Kardiochirurgii Uniwersyteckiego Szpitala Klinicznego w Lodzi
state: Kniaziewicza 1/5
city: Krakow
country: Poland
facility: II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow
state: Kopernika 17
Study officials:
affiliation: II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow
name: Jacek Legutko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: