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Status unknownNCT00766129Updated Jul 6, 2011

Comparison of Safety and Efficacy of Two Different Drug Eluting Stents Implanted Into Saphenous Vein Grafts

A Phase 3 interventional study of Taxus stent implantation and Luc-Chopin stent in Stenosis in Saphenous Vein Graft, Drug Eluting Stent, sponsored by National Institute of Cardiology, Warsaw, Poland. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-07-06.

Sponsored by National Institute of Cardiology, Warsaw, Poland · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary arteries. There are several kinds of DES i.e. eluting the drug either from stable or biodegradable polymer. The type of the polymer may impact the clinical outcome. The aim of our study was to compare safety and efficacy of implantation of two different types of stents eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent) into coronary artery by-pass graft.

02

Conditions studied

  • Stenosis in Saphenous Vein Graft, Drug Eluting Stent

Keywords

  • saphenous vein graft, TAXUS stent, Chopin stent
03

In context

Lead sponsor

National Institute of Cardiology, Warsaw, Poland is the lead sponsor of 53 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Atherosclerotic lesion in saphenous vein grafts causing angiographic stenosis ≥70%
  2. Stable coronary artery disease or non ST segment elevation acute coronary syndrome
  3. Reference segment diameter in range of 2.5-4.5mm

Exclusion criteria

Exclusion Criteria:

  1. Cardiogenic shock
  2. Contraindications to prolonged dual antiplatelet therapy
  3. Female of child birth potential unless on effective contraception
  4. Other medical condition that may limit survival
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    T

    Implantation of Taxus stent into saphenous vein graft

    Device: Taxus stent implantation

  • Experimental
    C

    Implantation of Luc-Chopin stent into saphenous vein graft

    Device: Luc-Chopin stent

Interventions

  • DeviceTaxus stent implantation

    Patients will be treated with implantation of Taxus stent

  • DeviceLuc-Chopin stent

    Patients will be treated will implantation of Luc-Chopin stent

06

What researchers measure

Primary outcomes

  1. Neointima hyperplasia volume by Intravascular Ultrasound

    Time frame: 9 months

Secondary outcomes

  1. All cause mortality

    Time frame: 5 years

  2. Cardiovascular mortality

    Time frame: 5 years

  3. Stent thrombosis

    Time frame: 5 years

  4. Target lesion revascularization

    Time frame: 5 years

  5. Angiographic late loss

    Time frame: 9 months

07

Study locations

1 site
  • Institute of Cardiology
    Warsaw, 04-628, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00766129
Lead sponsor
National Institute of Cardiology, Warsaw, Poland
First posted
Oct 3, 2008
Start date
Feb 2008
Primary completion
Apr 2011
Completion
Dec 2011 (estimated)
Last update
Jul 6, 2011

Study contacts

Adam R Witkowski, MD,PhD
principal investigator · National Institute of Cardiology, Warsaw, Poland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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