coronary artery lesions
Conditions
Interventions
The treatment strategy for all patients enrolled in the Spirit V Diabetic study
is as follows:
Patients may receive up to 4 planned stents, depending on the number of vessels
treated and their respe
Sponsors
Abbott
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Maximum of one, de novo, target lesion per native major epicardial vessel or side branch (no prior stent implant, no prior brachytherapy Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate Target lesion 50% and 1 Spirit V Registry: According tot he instructions for Use (IFU)
Exclusion criteria
Exclusion criteria: Patient has had a known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure Patient has current unstable arrhythmias Patient has a known left ventricular ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the SPIRIT V Diabetic Study is in-stent Late Loss (LL) at 270 days. The primary endpoint of the SPIRIT V Registry is Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) at 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| SPIRIT V Diabetic Study: Acute Success (Clinical Device Success and Clinical Procedure Success); Adjudicated Stent Thrombosis at 30 days, 240 days, 1, 2, 3, 4 and 5 years:(Confirmed/definite, Probable, Possible) In-segment, proximal and distal Late Loss at 270 days: In-stent and in-segment Angiographic Binary Restenosis rates at 270 days; In-stent and in-segment percent Diameter Stenosis at 270 days; Adjudicated Target Lesion Revascularization (TLR) rate at 30 days, 240 days, 1, 2, 3, 4 and 5 years (both Clinical-indicated and not clinical-indicated); Adjudicated Composite rate of Cardiac Death, Myocardial Infarction (MI) and Clinical-indicated Target Lesion; Revascularization (CI-TLR) at 30 days, 240 days, 1, 2, 3, 4 and 5 years; Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) at 30 days, 240 days, 1, 2, 3, 4 and 5 years. The primary endpoint of the SPIRIT V Registry is Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) at 30 days. Spirit V Registry: Acute Success (Clinical Device Success and Clinical Procedure Success); Adjudicated Stent Thrombosis at 30 days, and at 1 and 2 years (Confirmed/definite, Probable, Possible) Adjudicated TLR at 30 days, 1 and 2 years; Adjudicated Composite rate of Cardiac Death, MI and CI-TLR at 30 days, 1 and 2 years; Adjudicated Composite rate of All Death, MI and TVR at 1 and 2 years | — |
Countries
Netherlands
Outcome results
None listed