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

NitiLoop

Status: Completed

Conditions: Chronic Total Occlusion

Treatments: Device: NovaCross™ microcatheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02358629

NT-CPEX-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

14 participants in 1 patient group

Prospective, non-randomized

Experimental group

Description:

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

Treatment:

Device: NovaCross™ microcatheter