I25
Conditions
Interventions
Group 1: Placement of a stent in combination with the GUIDEPLUS II guide extension catheter for endovascular treatment of lesions in coronary arteries.
Sponsors
NIPRO CORPORATION
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol • The patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document • Patients with coronary heart disease and intended for coronary endovascular therapy • Patients with lesions suitable for percutaneous coronary intervention (PCI) and stent delivery • Investigator considers implanting stent is difficult to deliver itself to the target lesion
Exclusion criteria
Exclusion criteria: • Patients severely symptomatic and possible unavailability for follow up assessment as regulated by Clinical Investigation Plan. • Patients who are not suitable for stenting due to intolerance to aspirin and/or clopidogrel • Severe allergy to contrast media • Cardiogenic shock • Hemorrhagic diathesis or another disorder associated with increased bleeding risk such as gastrointestinal ulceration, which restricts the use of platelet aggregation inhibitor therapy and anticoagulation therapy • Acute myocardial infarction (MI) within the past 72 hours with presence of intravascular thrombus or poor coronary blood flow • Lesions not suitable for interventional treatment • Reference vessel diameter (RVD) 2.0mm • Lesion at Graft • Primary PCI in acute ST-elevation myocardial infarction • Patients who are concurrently participating in an investigational study when such participation could confound the treatment or outcomes of this study • Patients under administrative or judicial custody (§27 Medical Device Implementing Act, MPDG, Germany)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of device success. Device Success is defined as a case in which a stent in combination with the GUIDEPLUS II guide extension catheter is successfully delivered to the target lesion regardless of success or failure of stent expansion on the lesion. The endpoint will be assessed immediately after intervention by the investigators. | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedural success rate. Procedural Success is defined as a case which obtains TIMI 3 flow at final angiogram after device success and visual improvement of the target area after stent placement. The endpoint will be assessed immediately after intervention by the investigators. | — |
Countries
Germany
Contacts
Public ContactBruno Scheller
University of Saarland, Clinical and Experimental Interventional Cardiology, Internal Medicine III
Outcome results
None listed