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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Total Occlusion
• Intervention / Treatment: Device: NovaCross™ microcatheter

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland
    • Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective, non-randomized; use 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Events	absence of in-hospital or 30-days Major Adverse Events (MAEs)	30 days
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

Collaborators and Investigators

• Sponsor: Nitiloop Ltd.
• Investigators: Study Chair: Chanan Schneider, Nitiloop Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 9, 2015

Study Record Updates

• Last Update Posted (Estimate): September 21, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: NT-CPEX-01