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

NCT02358629 | Completed

• 1 other identifier: NT-CPEX-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Total Occlusion

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Prospective, non-randomized

EXPERIMENTAL

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

Interventions

NovaCross™ microcatheter 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

Prospective, non-randomized

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged 25-80
• Patient understands and has signed the study informed consent form.
• Patient has symptomatic peripheral artery disease (PAD) requiring endovascular revascularization of a CTO, evidenced by angiography, computed tomography or magnetic resonance angiography.
• Patient has an occluded femoropopliteal or infra popliteal artery
• Target femoropopliteal or infra-popliteal vessel is ≥ 2.5 mm and ≤5 mm in diameter.
• Patient has Rutherford-Becker Classification of 2-5.

You may not qualify if:

• Patient unable to give informed consent.
• Current participation in another study with any investigational drug or device.
• Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
• Patient has a known sensitivity or allergy to anti-platelet medications.
• Patient is pregnant or lactating.
• Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
• Target lesion is in a bypass graft.
• Target lesion is in a stent (i.e., in-stent restenosis).
• Patient has had a procedure on the target limb within 7 days.
• 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.
• Vasculitis and Buerger disease (thrombendarteritis obliterans)
• Evidence of embolism
• Peripheral vessel aneurysm

Sponsors & Collaborators

• Nitiloop Ltd.: lead

Study Sites (1)

Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, Poland

Location

Study Officials

• Chanan Schneider

  Nitiloop Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 9, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 21, 2016

Record last verified: 2016-09

Locations

PL (1)