NCT01255956

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

January 25, 2011

Status Verified

January 1, 2011

Enrollment Period

1.6 years

First QC Date

December 6, 2010

Last Update Submit

January 24, 2011

Conditions

In-Stent Restenosis

Keywords

restenosisISRin-stent restenosisdrug eluting stentrapamycin eluting stentpaclitaxel eluting balloon catheter

Outcome Measures

Primary Outcomes (3)

  • 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 (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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

Rapamycin eluting stent implantationDEVICE

Rapamycin eluting stent implantation for in-stent restenosis treatment

Rapamycin eluting stent
Paclitaxel eluting balloon catheterDEVICE

Paclitaxel eluting balloon catheter for in-stent restenosis treatment

Paclitaxel eluting balloon catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Instytut Kardiologii w Warszawie-Aninie

Warsaw, Alpejska 42, 04-628, Poland

RECRUITING

Katedra i Klinika Kardiologii Warszawskiego Uniwersytetu Medycznego

Warsaw, Banacha 1a, 02-097, Poland

RECRUITING

Klinika Kardiologii z Kliniką Kardiochirurgii Uniwersyteckiego Szpitala Klinicznego w Lodzi

Lodz, Kniaziewicza 1/5, 91-347, Poland

RECRUITING

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

Krakow, Kopernika 17, 31-500, Poland

RECRUITING

Study Officials

  • Jacek Legutko, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 8, 2010

Study Start

December 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 25, 2011

Record last verified: 2011-01

Locations

PL(4)