PCI CTO stenosis
Conditions
Interventions
The anterograde approach is the first choice technique in the vast majority of
percutaneous interventions of CTOs. After choosing the adequate guiding
catheter for maximal back-up support, and ensur
Sponsors
Nitiloop Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult aged 25-80 2. Patient understands and has signed the study informed consent form. 3. Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0. 4. Suitable candidate for non-emergent, coronary angioplasty 5. Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches with the following characteristics: a) Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days; b) Satisfactory distal vessel visualization c) CTO should be amenable to percutaneous treatment and must be located in a coronary vessel with a reference diameter of at least 2 millimeters. d) CTO refractory to a minimum of 10 minutes of conventional guide wire attempt. 6. Body Mass Index (BMI) 25% For the purpose of this trial, a CTO is defined as a 100% luminal narrowing without antegrade flow or
Exclusion criteria
Exclusion criteria: 1. Patient unable to give informed consent. 2. Current participation in another study with any investigational drug or device. 3. Patient is known or suspected not to tolerate the contrast agent. 4. Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent CTO. 5. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor). 6. Appearance of a fresh thrombus or intraluminal filling defects. 7. Recent major cerebrovascular event (history of stroke or TIA within 1 month) 8. Cardiac intervention within 4 weeks of the procedure 9. Renal insufficiency (serum creatinine of > 2.3mg/dl or 203umol/L) 10. Active gastrointestinal bleeding 11. Active infection or fever that may be due to infection 12. Life expectancy 240 mmHg within 1 month of procedure) 15. Severe electrolyte imbalance 16. Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV. 17. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) 18. Recent myocardial infarction (MI) (within the past two weeks) 19. Uncontrolled diabetes >2 serum glucose concentrations of >350 mg/dl within 7 days. 20. Unwillingness or inability to comply with any protocol requirements 21. Pregnant or nursing 22. Extensive prior dissection from a coronary guidewire use 23. Drug abuse or alcoholism. 24. Patients under custodial care. 25. Bleeding diathesis or coagulation disorder; 26. Kawasaki's disease or other vasculitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: 30 day MACE, defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)). Primary Effectiveness Endpoint: Intra-procedural technical success Defined as the ability of the NovaCross* microcatheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion (CTO) in the true vessel lumen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: The following objectives are pre-specified but are not intended to support product labeling: 1) The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow. 2) The ability of the NovaCross* micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO. 3) The effectiveness of the extendable portion in intra-CTO microcatheter crossability. 4) The ability to have full visualization of the NovaCross during the CTO procedure. 5) Assess the usability of the NovaCross* by the operator. 6) Device-related perforation at the site of target coronary lesion and/or its proximal reference segment. | — |
Countries
Netherlands
Outcome results
None listed