Late clinical events after paclitaxel- vs. zotarolimus-eluting stents in patients with small vessel stenting

BAsel Stent Kosten Effektivitäts Trial - late clinical events in patients with SMALL vessel stenting

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN09125734

Enrollment

200

Registered

2007-03-06

Start date

2007-03-01

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 diesease Circulatory System Coronary artery diesease

Interventions

Interventions as of 09/05/2016: Randomization will be 1:1 to Taxus® (standard 1st generation DES with paclitaxel) versus Endeavor® (2nd generation DES with zotarolimus). Origianl interventions: Rando

Eligibility

Inclusion criteria

Inclusion criteria: 1. All comers, 24 hours a day, 7 days a week, irrespective of indication for percutaneous coronary intervention (PCI) 2. With the need of small vessel stenting (at least one stent <3.0 mm)

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 6 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
Primary outcome measures as of 09/05/2016: Absence of both major adverse cardiac events (MACE), i.e., of the following: 1. Cardiac death (all death not clearly of extra cardiac origin) 2. Documented non-fatal Myocardial Infarction (MI) (according to the current European Society of Cardiology [ESC]-guidelines) 3. Non-MI-related target vessel revascularization (TVR) All after 18 months Original primary outcome measures: Absence of both of the following: 1. Cardiac death (all death not clearly of extra cardiac origin) 2. Documented non-fatal Myocardial Infarction (MI) (according to the current European Society of Cardiology [ESC]-guidelines) after 18 months	—

Measure

Time frame

Primary outcome measures as of 09/05/2016: Absence of both major adverse cardiac events (MACE), i.e., of the following: 1. Cardiac death (all death not clearly of extra cardiac origin) 2. Documented non-fatal Myocardial Infarction (MI) (according to the current European Society of Cardiology [ESC]-guidelines) 3. Non-MI-related target vessel revascularization (TVR) All after 18 months Original primary outcome measures: Absence of both of the following: 1. Cardiac death (all death not clearly of extra cardiac origin) 2. Documented non-fatal Myocardial Infarction (MI) (according to the current European Society of Cardiology [ESC]-guidelines) after 18 months

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Secondary

Measure	Time frame
Secondary outcome measures as of 09/05/2016: 1. Primary end-point events up to 12 and 24 months 2. Non-cardiac death (total death) 3. Major non-coronary artery bypass graft (CABG) bleeding (need for surgery, blood transfusions, cerebral hemorrhages) during dual antiplatelet therapy (up to 12 months) ? ? 4. Net clinical benefit? = primary end-point + bleeding Subgroups with: a. Diabetes b. Acute coronary syndrome c. ST-elevation myocardial infarction (MI) d. Need for glycoprotein (GP) IIb/IIIa inhibitors e. Lesions >25 mm f. All stents 25 mm f. All stents < 3mm	—

Measure

Time frame

Secondary outcome measures as of 09/05/2016: 1. Primary end-point events up to 12 and 24 months 2. Non-cardiac death (total death) 3. Major non-coronary artery bypass graft (CABG) bleeding (need for surgery, blood transfusions, cerebral hemorrhages) during dual antiplatelet therapy (up to 12 months) ? ? 4. Net clinical benefit? = primary end-point + bleeding Subgroups with: a. Diabetes b. Acute coronary syndrome c. ST-elevation myocardial infarction (MI) d. Need for glycoprotein (GP) IIb/IIIa inhibitors e. Lesions >25 mm f. All stents 25 mm f. All stents < 3mm

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Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026