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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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Drug eluting stent
Device: Bare metal stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: BAsel Stent Kosten Effektivitäts Trial - SAphenous Venous Graft Angioplasty Using Glycoprotein IIb/IIIa Receptor Inhibitors and Drug-Eluting Stents

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: February 2008
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Percutaneous coronary intervention
Device: Drug eluting stent
Implantation of stent
Other Name: TAXUS Liberté
Placebo Comparator: 2
Percutaneous coronary intervention
Device: Bare metal stent
Implantation of stent
Other Name: Liberté

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595647

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark
Gentofte Hospital
Hellerup, Denmark
Germany
University of Leipzig/Heart Center
Leipzig, Germany
Switzerland
University Hospital Basel
Basel, Switzerland
Triemli Hospital
Zurich, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Leipzig
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
  More Information

No publications provided

Responsible Party: Raban Jeger, PD Dr. med. / MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00595647     History of Changes
Other Study ID Numbers: BASKET-SAVAGE EKBB# 278/07, SNF 3200B0_120029, EKBB 278/07
Study First Received: January 4, 2008
Last Updated: June 18, 2013
Health Authority: Switzerland: Ethikkommission
Germany: Ethics Commission

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014