Evaluation of late clinical events after drug-eluting versus bare-metal stents in patients at risk

Evaluation of late clinical events after drug-eluting versus bare-metal stents in patients at risk: BAsel Stent Kosten Effektivitäts Trial - PROspective Validation Examination

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72444640

Enrollment

2400

Registered

2007-02-01

Start date

2007-02-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease Circulatory System Coronary artery disease

Interventions

Patients will be randomised to: 1. 1:1 to PCI and Stent placement with Cypher-Select® (standard first generation DES) versus Vision® (third generation cobalt-chromium BMS) 2. 1:1 to Xience® (DES with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All comers, 24 hours a day, seven days a week, irrespective of indication for Percutaneous Coronary Intervention (PCI) 2. With the need for large (more than or equal to 3.0 mm stents only) native vessel stenting

Exclusion criteria

Exclusion criteria: 1. In-stent-restenosis 2. Bypass graft disease 3. Main stem disease to be stented 4. Cardiogenic shock 5. Planned surgery within the next six months 6. Oral anticoagulation needed (artificial heart valves, atrial fibrillation) 7. No compliance expected 8. Enrolled in another study 9. No consent

Design outcomes

Primary

Measure	Time frame
Freedom of combination of: 1. Cardiac death (all death not clearly of extra cardiac origin) 2. Documented non-fatal MI (according to the current European Society of Cardiology [ESC]-guidelines after 24 months	—

Secondary

Measure	Time frame
1. Non-MI related Target Vessel Revascularisation (TVR) 2. Major Adverse Cardiac Events (MACE) = primary outcomes and non-MI related TVR 3. Primary outcomes up to 18 and 36 months (for comparison with BASKET and BASKET-LATE) 4. Components of the primary outcomes 5. Non-cardiac death (total death) 6. Major non-Coronary Artery Bypass Graft (CABG) bleeding (need for surgery, blood transfusions, cerebral haemorrhages) during dual antiplatelet therapy (up to twelve months) - ?net clinical benefit? = primary outcomes and bleeding 7. Subgroups with: a. diabetes b. acute coronary syndrome c. ST-elevation MI d. need for GlycoProtein (GP) IIb/IIIa inhibitors e. lesions more than 25 mm	—

Measure

Time frame

1. Non-MI related Target Vessel Revascularisation (TVR) 2. Major Adverse Cardiac Events (MACE) = primary outcomes and non-MI related TVR 3. Primary outcomes up to 18 and 36 months (for comparison with BASKET and BASKET-LATE) 4. Components of the primary outcomes 5. Non-cardiac death (total death) 6. Major non-Coronary Artery Bypass Graft (CABG) bleeding (need for surgery, blood transfusions, cerebral haemorrhages) during dual antiplatelet therapy (up to twelve months) - ?net clinical benefit? = primary outcomes and bleeding 7. Subgroups with: a. diabetes b. acute coronary syndrome c. ST-elevation MI d. need for GlycoProtein (GP) IIb/IIIa inhibitors e. lesions more than 25 mm

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Countries

Denmark, Norway, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026