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Study to Test the Efficacy and Safety of Drug Eluting vs. Bare-Metal Stents for Saphenous Vein Graft Interventions (BASKET-SAVAGE)

This study has been terminated.
Sponsor:
Collaborator:
University of Leipzig
Information provided by (Responsible Party):
Raban Jeger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00595647
First received: January 4, 2008
Last updated: June 18, 2013
Last verified: June 2013

January 4, 2008
June 18, 2013
February 2008
March 2014   (final data collection date for primary outcome measure)
MACE (composite of cardiac death, i.e., all deaths not clearly non-cardiac, non-fatal myocardial infarction, and TVR [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00595647 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Test the Efficacy and Safety of Drug Eluting vs. Bare-Metal Stents for Saphenous Vein Graft Interventions
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Drug eluting stent
    Implantation of stent
    Other Name: TAXUS Liberté
  • Device: Bare metal stent
    Implantation of stent
    Other Name: Liberté
  • Active Comparator: 1
    Percutaneous coronary intervention
    Intervention: Device: Drug eluting stent
  • Placebo Comparator: 2
    Percutaneous coronary intervention
    Intervention: Device: Bare metal stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
240
March 2018
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany,   Switzerland
 
NCT00595647
BASKET-SAVAGE EKBB# 278/07, SNF 3200B0_120029, EKBB 278/07
Yes
Raban Jeger, University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
University of Leipzig
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
University Hospital, Basel, Switzerland
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP