Study to Test the Efficacy and Safety of Drug Eluting vs. Bare-Metal Stents for Saphenous Vein Graft Interventions (BASKET-SAVAGE)
April 19, 2015 updated by: Raban Jeger, University Hospital, Basel, Switzerland
BAsel Stent Kosten Effektivitäts Trial - SAphenous Venous Graft Angioplasty Using Glycoprotein IIb/IIIa Receptor Inhibitors and Drug-Eluting Stents
Prospective multicenter controlled randomized trial to compare the safety and efficacy of drug eluting vs. bare metal stents in percutaneous coronary interventions of saphenous vein grafts.
Hypothesis: Survival and outcome will be significantly better in patients receiving DES than in patients receiving BMS regarding both short-term and long-term outcome.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Research Question: What is the effect of the paclitaxel eluting TAXUS® Liberté® stent compared with the bare-metal Liberté® stent (both Boston Scientific Corporation, Natick, MA) in saphenous vein graft (SVG) percutaneous coronary interventions (PCI) when used in conjunction with a glycoprotein IIb/IIIa inhibitor, e.g., abciximab (ReoPro®, Eli Lilly & Co., Indianapolis, IN), and a distal filter system?
Design: Prospective, multicenter, controlled randomized trial.
Subjects: Inclusion criteria: Patients undergoing SVG PCI with a target vessel reference diameter ≤ 5.5 mm (visual estimate); documented silent ischemia, stable angina pectoris Canadian Cardiovascular Society (CCS) class I to IV, or acute coronary syndrome.
Exclusion criteria: Previous stent implantation anywhere in the target SVG; concomitant native vessel PCI; SVG age <6 months; arterial grafts; oral anticoagulation; platelet count <100x109/L or >700x109/L; any major non-cardiac condition with a life expectancy <12 months; known allergies against the components tested; white blood cell count <3000 cell/mm3; enrolled in other study; no consent; patients unlikely to comply to the study treatment and the follow-up visits.
Recruitment: Consecutive sample of all patients who qualify Variables: Predictor: Randomization will be single-blinded 1:1 to the TAXUS® Liberté® vs. the Liberté® stent (both Boston Scientific Corporation, Natick, MA).
In all patients, a distal filter system will be used during PCI.
The use of a glycoprotein IIb/IIIa inhibitor, e.g., abciximab (ReoPro®, Eli Lilly & Co., Indianapolis, IN), will be strongly recommended (bolus prior to PCI and 12 h infusion post PCI).
Outcome: Primary: MACE after 12 months.
MACE will be defined as the composite of cardiac death (all deaths not clearly non-cardiac), non-fatal myocardial infarction, and TVR.
Secondary: Non-fatal myocardial infarction and cardiac death at 30 days and 6, 12, 36, and 60 months; MACE at 30 days and 6, 36, and 60 months; quality of life; individual components of the primary endpoint; non-cardiac death; major bleeding, defined as need for surgery, need for blood transfusions, and cerebral hemorrhage during antiplatelet therapy; minor bleeding, defined as a drop in hematocrit of >2 mg/dL.
Study Type
Interventional
Enrollment (Actual)
162
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark
- Rigshospitalet
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Hellerup, Denmark
- Gentofte Hospital
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Leipzig, Germany
- University of Leipzig/Heart Center
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Basel, Switzerland
- University Hospital Basel
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Zurich, Switzerland
- Triemli Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing SVG PCI with a target vessel reference diameter ≤ 5.5 mm (visual estimate)
- Documented silent ischemia, stable angina pectoris Canadian Cardiovascular Society (CCS) class I to IV, or acute coronary syndrome
Exclusion Criteria:
- Previous stent implantation anywhere in the target SVG
- Concomitant native vessel PCI
- SVG age <6 months
- Arterial grafts
- Oral anticoagulation
- Platelet count <100x109/L or >700x109/L, white blood cell count <3000 cells/mm3
- Any major non-cardiac condition with a life expectancy <12 months
- Planned elective surgery in the next 12 months
- Known allergies against the components tested
- Enrolled in other study
- No consent
- Patients unlikely to comply to the study treatment and the follow-up visits
- Age <18 years
- Known pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 1
Percutaneous coronary intervention
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Implantation of stent
Other Names:
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Placebo Comparator: 2
Percutaneous coronary intervention
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Implantation of stent
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
MACE (composite of cardiac death, i.e., all deaths not clearly non-cardiac, non-fatal myocardial infarction, and TVR
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Non-fatal MI and cardiac death; MACE; QoL; individual components of the primary endpoint; non-cardiac death; major bleeding; minor bleeding
Time Frame: 30 days and 6, 12, 36, and 60 months
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30 days and 6, 12, 36, and 60 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Matthias Pfisterer, MD, University Hospital, Basel, Switzerland
- Principal Investigator: Raban Jeger, MD, University Hospital, Basel, Switzerland
- Principal Investigator: Sven Möbius-Winkler, MD, University of Leipzig/Heart Center, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
January 4, 2008
First Submitted That Met QC Criteria
January 15, 2008
First Posted (Estimate)
January 16, 2008
Study Record Updates
Last Update Posted (Estimate)
April 21, 2015
Last Update Submitted That Met QC Criteria
April 19, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASKET-SAVAGE EKBB# 278/07
- SNF 3200B0_120029 (Other Grant/Funding Number: Schweizer Nationalfond)
- EKBB 278/07 (Other Identifier: Ethics Committee)
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