Status:
UNKNOWN
Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA)
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
KCRI
Conditions:
In-Stent Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 r...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01255956
Start Date
December 1 2010
End Date
July 1 2012
Last Update
January 25 2011
Active Locations (4)
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1
Instytut Kardiologii w Warszawie-Aninie
Warsaw, Alpejska 42, Poland, 04-628
2
Katedra i Klinika Kardiologii Warszawskiego Uniwersytetu Medycznego
Warsaw, Banacha 1a, Poland, 02-097
3
Klinika Kardiologii z Kliniką Kardiochirurgii Uniwersyteckiego Szpitala Klinicznego w Lodzi
Lodz, Kniaziewicza 1/5, Poland, 91-347
4
II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow
Krakow, Kopernika 17, Poland, 31-500