Comparison of Safety and Efficacy of Two Different Drug Eluting Stents Implanted Into Saphenous Vein Grafts - Full Text View

Sponsor:	Institute of Cardiology, Warsaw, Poland
Information provided by:	Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:	NCT00766129

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

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:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
T: Experimental Implantation of Taxus stent into saphenous vein graft	Device: Taxus stent implantation Patients will be treated with implantation of Taxus stent
C: Experimental 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:

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

Exclusion Criteria:

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

Contacts and Locations

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

Contacts

Contact: Adam R Witkowski, MD,PhD	+48 22 3434340	witkowski@hbz.pl
Contact: Jerzy M Pregowski, MD,PhD	+48 501 472 421	jerzy_pregowski@yahoo.com

Locations

Poland
Institute of Cardiology	Recruiting
Warsaw, Poland, 04-628
Contact: Adam R Witkowski, MD,PhD +48 22 3434340 witkowski@hbz.pl
Contact: Jerzy M Pregowski, MD,PhD +48 501 472 421 jerzy_pregowski@yahoo.com
Sub-Investigator: Jerzy M Pregowski, MD, PhD

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:	Institute of Cardiology,Warsaw,Poland ( Adam Witkowski )
Study ID Numbers:	N403 2786 33
Study First Received:	October 2, 2008
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00766129 History of Changes
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 February 08, 2010