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

Phase 3

• Conditions: In-Stent Restenosis
• Interventions: Device: Rapamycin eluting stent implantation; Device: Paclitaxel eluting balloon catheter

• Registration Number: NCT01255956
• Lead Sponsor: Medical University of Warsaw

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)

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-08
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapamycin eluting stent	Rapamycin eluting stent implantation	Patients treated with rapamycin eluting stent (n=100)
Paclitaxel eluting balloon catheter	Paclitaxel eluting balloon catheter	Patients treated with paclitaxel eluting balloon catheter (n=100)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Klinika Kardiologii z Kliniką Kardiochirurgii Uniwersyteckiego Szpitala Klinicznego w Lodzi; 🇵🇱 Lodz, Kniaziewicza 1/5, Poland

Katedra i Klinika Kardiologii Warszawskiego Uniwersytetu Medycznego; 🇵🇱 Warszawa, Banacha 1a, Poland

II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow; 🇵🇱 Krakow, Kopernika 17, Poland

Instytut Kardiologii w Warszawie-Aninie; 🇵🇱 Warszawa, Alpejska 42, Poland