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

In-Stent Restenosis Clinical Trial

— ISRII  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01255956
• Other study ID #: Restenoza II 4.0
• Status: Recruiting
• Phase: Phase 3
• First received: December 6, 2010
• Last updated: January 24, 2011
• Start date: December 2010
• Est. completion date: July 2012

Study information

• Verified date: January 2011
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• In-Stent Restenosis

Intervention

Device:
• Rapamycin eluting stent implantation
Rapamycin eluting stent implantation for in-stent restenosis treatment
• Paclitaxel eluting balloon catheter
Paclitaxel eluting balloon catheter for in-stent restenosis treatment

Locations

Country	Name	City	State
Poland	II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow	Krakow	Kopernika 17
Poland	Klinika Kardiologii z Klinika Kardiochirurgii Uniwersyteckiego Szpitala Klinicznego w Lodzi	Lodz	Kniaziewicza 1/5
Poland	Instytut Kardiologii w Warszawie-Aninie	Warszawa	Alpejska 42
Poland	Katedra i Klinika Kardiologii Warszawskiego Uniwersytetu Medycznego	Warszawa	Banacha 1a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	KCRI

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of repeated restenosis angiographically evidenced		at 9 months	No
Primary	Neointimal volume assessed by intravascular ultrasound (IVUS)		at 9 months	No
Primary	Late lumen loss and neointimal volume assessed by optical coherence tomography (OCT)		at 9 months	No
Secondary	Incidence of repeated target lesion revascularization (TLR)		at 9 months	Yes
Secondary	Incidence of repeated target vessel revascularization (TVR)		at 9 months	Yes
Secondary	Incidence of death		at 9 months	Yes
Secondary	Incidence of myocardial infarction		at 9 months	Yes
Secondary	Incidence of brain stroke		at 9 months	Yes
Secondary	Incidence of in-stent thrombosis		at 9 months	No