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

Not Applicable

Completed

• Conditions: Chronic Total Occlusion
• Interventions: Device: NovaCross™ microcatheter

• Registration Number: NCT02358629
• Lead Sponsor: Nitiloop Ltd.

Brief 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.

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 Timeline

• Study First Submitted: 2015-01-30
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective, non-randomized	NovaCross™ microcatheter	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

Primary Outcome Measures

Name	Time	Method
Major Adverse Events	30 days	absence of in-hospital or 30-days Major Adverse Events (MAEs)
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	in procedure	Successful femoropopliteal/infra popliteal CTO crossing using the NovaCross™ micro-catheter

Trial Locations

Locations (1)

Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie; 🇵🇱 Krakow, Poland