A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO).

Chronic Total Occlusion Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358629
• Other study ID #: NT-CPEX-01
• 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

• Chronic Total Occlusion

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