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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02358629
Other study ID # NT-CPEX-01
Secondary ID
Status Completed
Phase N/A
First received January 30, 2015
Last updated September 20, 2016
Start date February 2015
Est. completion date July 2016

Study information

Verified date September 2016
Source Nitiloop Ltd.
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.


Description:

This is an open label, single center, prospective, first in man pilot study in which the investigational device, NitiLoop micro-catheter, will be tested in up to 15 patients with symptomatic peripheral arterial occlusive disease scheduled to undergo CTO in an anterograde approach.


Recruitment information / eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
NovaCross™ microcatheter
successful delivery, crossing, and retrieval of the investigational device as identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography

Locations

Country Name City State
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Krakow

Sponsors (1)

Lead Sponsor Collaborator
Nitiloop Ltd.

Country where clinical trial is conducted

Poland, 

Outcome

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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