Restenosis Treatment With Rapamycin Eluting Stent or Pacl... | NCT01255956

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

NCT01255956

Sponsor

Medical University of Warsaw

Status

Unknown status

Last Update Posted

Jan 25, 2011Estimated

Enrollment

200Estimated

Phase

Phase 3

Conditions

In-Stent Restenosis

Interventions

Rapamycin eluting stent implantation
Paclitaxel eluting balloon catheter

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Jul 2012Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Dec 6, 2010

First Submission Date that Met QC Criteria

Dec 7, 2010

First Posted Date

Dec 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2011

Last Update Posted Date

Jan 25, 2011Estimated

Name	Class
KCRI	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rapamycin eluting stent	Experimental	Patients treated with rapamycin eluting stent (n=100)	Device: Rapamycin eluting stent implantation
Paclitaxel eluting balloon catheter	Experimental	Patients treated with paclitaxel eluting balloon catheter (n=100)	Device: Paclitaxel eluting balloon catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rapamycin eluting stent implantation	Device	Rapamycin eluting stent implantation for in-stent restenosis treatment	Rapamycin eluting stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Incidence of repeated target lesion revascularization (TLR)		at 9 months
Incidence of repeated target vessel revascularization (TVR)		at 9 months
Incidence of death

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacek Legutko, MD, PhD	II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instytut Kardiologii w Warszawie-Aninie	Recruiting	Warsaw	Alpejska 42	04-628	Poland