Chronic Total Occlusion Clinical Trial
Verified date | September 2016 |
Source | Nitiloop Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Commission |
Study type | Interventional |
Trial is to evaluate the safety and performance of the NovaCross™micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of femoropopliteal and infra-popliteal Chronic Total Occlusion (CTO) lesion. The procedure will be conducted on a patient diagnosed with a CTO in a peripheral vessel that requires revascularization.
Status | Completed |
Enrollment | 14 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Adult aged 25-80 2. Patient understands and has signed the study informed consent form. 3. Patient has symptomatic peripheral artery disease (PAD) requiring endovascular revascularization of a CTO, evidenced by angiography, computed tomography or magnetic resonance angiography. 4. Patient has an occluded femoropopliteal or infra popliteal artery 5. Target femoropopliteal or infra-popliteal vessel is = 2.5 mm and =5 mm in diameter. 6. Patient has Rutherford-Becker Classification of 2-5. Exclusion Criteria: 1. Patient unable to give informed consent. 2. Current participation in another study with any investigational drug or device. 3. Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated. 4. Patient has a known sensitivity or allergy to anti-platelet medications. 5. Patient is pregnant or lactating. 6. Patient has a co-existing disease or medical condition contraindicating percutaneous intervention. 7. Target lesion is in a bypass graft. 8. Target lesion is in a stent (i.e., in-stent restenosis). 9. Patient has had a procedure on the target limb within 7 days. 10. Patient had undergone attempted treatment of the CTO within the prior 3 months (to prevent a guidewire from entering dissection planes created by prior recanalization attempts. 11. Vasculitis and Buerger disease (thrombendarteritis obliterans) 12. Evidence of embolism 13. Peripheral vessel aneurysm |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Krakow |
Lead Sponsor | Collaborator |
---|---|
Nitiloop Ltd. |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major Adverse Events | absence of in-hospital or 30-days Major Adverse Events (MAEs) | 30 days | Yes |
Primary | Device success is defined as successful delivery, crossing, and retrieval of the investigational device as identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography | Successful femoropopliteal/infra popliteal CTO crossing using the NovaCross™ micro-catheter | in procedure | No |
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