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

NCT ID: NCT02358629

Last Updated: 2016-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-07-31

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.

Conditions

Chronic Total Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

NovaCross™ microcatheter

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nitiloop Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chanan Schneider

Role: STUDY_CHAIR

Nitiloop Ltd.

Locations

Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Countries

Poland

Other Identifiers

NT-CPEX-01

Identifier Type: -

Identifier Source: org_study_id