Percutaneous Coronary Intervention (PCI), Coronary atherosclerosis
Conditions
Interventions
Intervention will involve randomization of the type of DES (Orsiro or Synergy or Resolute integrity) used in study population.
Sponsors
Cardio Research Enschede BV
Eligibility
Inclusion criteria
Inclusion criteria: 1. Minimum age of 18 years; 2. Significant coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement; 3. Capable of providing informed consent; 4. Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated.
Exclusion criteria
Exclusion criteria: 1. Known intolerance to components of one of the stents that will be investigated or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to dual antiplatelet therapy; 2. Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization; 3. Participation in another randomized drug or device trial before reaching primary endpoint; 4. Adherence to scheduled follow-up is unlikely or life expectancy assumed to be less than 1 year; 5. Known pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Target vessel failure (TVF) at 12 months (according to ARC definitions) after randomization of Orsiro and Synergy will be compared to Resolute Integrity. Components of the primary endpoint in hierarchical order: 1. Cardiac death. All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established; 2. Target vessel related MI that is Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel; 3. Clinically driven repeated target vessel revascularization by means of CABG or PCI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Device and patient oriented effectivity and safety parameters such as target-lesion failure, major adverse cardiac events and patient oriented composite endpoint and stent thrombosis, as well as clinical short- and long-term outcome, and the acute angiographic results of the implantation of Orsiro and Synergy will be compared to Resolute Integrity. | — |
Contacts
Public ContactH. Verheij
Medisch Spectrum Twente Haaksbergerstraat 55
Outcome results
None listed