coronary artery disease Symptomatic ischemic heart disease
Conditions
Interventions
All patients will receive the PRO-Kinetic stent
Sponsors
Biotronik
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient must be at least 18 years old Patients must be eligible for PTCA Documented stable (Canadian Cardiovascular Society Classification (CCS) 1,2,3 or 4) or unstable (Braunwald type I,II, III and A,B or C) angina pectoris, or documented silent ischemia. LVEF > 30 % documented within last 6 weeks
Exclusion criteria
Exclusion criteria: Planned treatment with any other PCI device in target vessel except the pre-dilatation balloon MI within 72 hours prior to the index procedure, or CK > 2 times the local upper limits of normal, measured on the day of the index procedure Patient is in cardiogenic shock CVA within last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is Target Vessel Failure (TVF) at 180 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints to be investigated in this trial include: • MACE (defined as cumulative incidence of total death, all MIs and TVR) at 30 (telephone FU) and 180 days (telephone FU) • TVR at 180 days (telephone FU), defined as a repeated procedure in the target vessel, thus including, but not only limited to, TLR. • In-stent and in-segment restenosisat 180 days (in the angiography subgroup) • Radiopacity • Device success • Procedure success • Lesion success | — |
Countries
Netherlands
Outcome results
None listed