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

Resource links provided by NLM:


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
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014