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

NCT ID: NCT01255956

Last Updated: 2011-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-07-31

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)

Conditions

In-Stent Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rapamycin eluting stent

Patients treated with rapamycin eluting stent (n=100)

Group Type: EXPERIMENTAL

Rapamycin eluting stent implantation

Intervention Type: DEVICE

Rapamycin eluting stent implantation for in-stent restenosis treatment

Paclitaxel eluting balloon catheter

Patients treated with paclitaxel eluting balloon catheter (n=100)

Group Type: EXPERIMENTAL

Paclitaxel eluting balloon catheter

Intervention Type: DEVICE

Paclitaxel eluting balloon catheter for in-stent restenosis treatment

Interventions

Rapamycin eluting stent implantation

Rapamycin eluting stent implantation for in-stent restenosis treatment

Intervention Type: DEVICE

Paclitaxel eluting balloon catheter

Paclitaxel eluting balloon catheter for in-stent restenosis treatment

Intervention Type: DEVICE

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

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCRI

OTHER

Sponsor Role: collaborator

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Medical University of Warsaw

Principal Investigators

Jacek Legutko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow

Locations

Instytut Kardiologii w Warszawie-Aninie

Warsaw, Alpejska 42, Poland

Site Status: RECRUITING

Katedra i Klinika Kardiologii Warszawskiego Uniwersytetu Medycznego

Warsaw, Banacha 1a, Poland

Site Status: RECRUITING

Klinika Kardiologii z Kliniką Kardiochirurgii Uniwersyteckiego Szpitala Klinicznego w Lodzi

Lodz, Kniaziewicza 1/5, Poland

Site Status: RECRUITING

II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow

Krakow, Kopernika 17, Poland

Site Status: RECRUITING

Countries

Poland

Facility Contacts

Adam Witkowski, MD, PhD

Role: primary

+48 22 812 41 64

Janusz Kochman, MD, PhD

Role: primary

+48 22 599 19 58

Zbigniew Peruga, MD, PhD

Role: primary

+48 42 251 62 21

Jacek Legutko, MD, PhD

Role: primary

+48 12 424 71 81

Other Identifiers

Restenoza II 4.0

Identifier Type: -

Identifier Source: org_study_id