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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Institute of Cardiology, Warsaw, Poland.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT00766129
First received: October 2, 2008
Last updated: July 4, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Stenosis in Saphenous Vein Graft, Drug Eluting Stent
Device: Taxus stent implantation
Device: Luc-Chopin stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Safety and Efficacy of Drug Eluting Stents : TAXUS (Boston Scientific) vs. LUC-Chopin (Balton, Poland) Implanted Into Saphenous Vein Grafts. Study With Serial Intravascular Ultrasounds.

Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • Neointima hyperplasia volume by Intravascular Ultrasound [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cardiovascular mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Angiographic late loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2008
Estimated Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T
Implantation of Taxus stent into saphenous vein graft
Device: Taxus stent implantation
Patients will be treated with implantation of Taxus stent
Experimental: C
Implantation of Luc-Chopin stent into saphenous vein graft
Device: Luc-Chopin stent
Patients will be treated will implantation of Luc-Chopin stent

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766129

Locations
Poland
Institute of Cardiology
Warsaw, Poland, 04-628
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
Principal Investigator: Adam R Witkowski, MD,PhD Institute of Cardiology, Warsaw, Poland
  More Information

No publications provided

Responsible Party: Adam Witkowski, Institute of Cardiology,Warsaw,Poland
ClinicalTrials.gov Identifier: NCT00766129     History of Changes
Other Study ID Numbers: N403 2786 33
Study First Received: October 2, 2008
Last Updated: July 4, 2011
Health Authority: Poland: Ministry of Health

Keywords provided by Institute of Cardiology, Warsaw, Poland:
saphenous vein graft, TAXUS stent, Chopin stent

ClinicalTrials.gov processed this record on April 15, 2014