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

Coronary Artery Disease Clinical Trial

— BASKET-SAVAGE  

Official title:

BAsel Stent Kosten Effektivitäts Trial - SAphenous Venous Graft Angioplasty Using Glycoprotein IIb/IIIa Receptor Inhibitors and Drug-Eluting Stents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00595647
• Other study ID #: BASKET-SAVAGE EKBB# 278/07
• Secondary ID: SNF 3200B0_12002
• Status: Terminated
• Phase: Phase 4
• First received: January 4, 2008
• Last updated: April 19, 2015
• Start date: February 2008
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 162
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Drug eluting stent
Implantation of stent
• Bare metal stent
Implantation of stent

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Gentofte Hospital	Hellerup
Germany	University of Leipzig/Heart Center	Leipzig
Switzerland	University Hospital Basel	Basel
Switzerland	Triemli Hospital	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University of Leipzig

Countries where clinical trial is conducted

Denmark,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE (composite of cardiac death, i.e., all deaths not clearly non-cardiac, non-fatal myocardial infarction, and TVR		12 months	Yes
Secondary	Non-fatal MI and cardiac death; MACE; QoL; individual components of the primary endpoint; non-cardiac death; major bleeding; minor bleeding		30 days and 6, 12, 36, and 60 months	Yes