A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross* Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions.
- Conditions
- PCI CTOstenosis1001108210003216
- Registration Number
- NL-OMON41722
- Lead Sponsor
- itiloop Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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) < 40
7. Left ventricle ejection fraction > 25%
For the purpose of this trial, a CTO is defined as a 100% luminal narrowing without antegrade flow or
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 < 2 years due to other illnesses
13. Significant anemia (hemoglobin < 8.0 mg / dl)
14. Severe uncontrolled systemic hypertension (> 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Safety Endpoint:<br /><br><br /><br>30 day MACE, defined as the composite of death, myocardial infarction (MI), or<br /><br>urgent revascularization (target vessel revascularization (TVR) or urgent<br /><br>coronary artery bypass surgery (CABG)).<br /><br><br /><br>Primary Effectiveness Endpoint:<br /><br><br /><br>Intra-procedural technical success Defined as the ability of the NovaCross*<br /><br>microcatheter to successfully facilitate placement of a guidewire beyond a<br /><br>native coronary chronic total occlusion (CTO) in the true vessel lumen.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br><br /><br>The following objectives are pre-specified but are not intended to support<br /><br>product labeling:<br /><br>1) The ability to cross the lesion with a guidewire in the true lumen,<br /><br>effectively dilate the CTO lesion, and place a coronary stent with residual<br /><br>lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow.<br /><br>2) The ability of the NovaCross* micro-catheter to facilitate a guidewire<br /><br>successfully penetrating the proximal cap of the CTO.<br /><br>3) The effectiveness of the extendable portion in intra-CTO microcatheter<br /><br>crossability.<br /><br>4) The ability to have full visualization of the NovaCross during the CTO<br /><br>procedure.<br /><br>5) Assess the usability of the NovaCross* by the operator.<br /><br>6) Device-related perforation at the site of target coronary lesion and/or its<br /><br>proximal reference segment.</p><br>