NL-OMON41722
Completed
Phase 2
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. - NT-CLP-01
itiloop Ltd.0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- PCI CTO
- Sponsor
- itiloop Ltd.
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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) \< 40
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
Outcomes
Primary Outcomes
Not specified
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