Chronic Total OcclusionNCT02358629
A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO).
A study testing NovaCross™ microcatheter in people with Chronic Total Occlusion, run by Nitiloop Ltd. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Chronic Total Occlusion
- What is being tested?
- NovaCross™ microcatheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow
About this study
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.
Read the 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
- Being tested
- NovaCross™ microcatheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaCross™ microcatheterDevice
successful delivery, crossing, and retrieval of the investigational device as identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: NovaCross™ microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events
absence of in-hospital or 30-days Major Adverse Events (MAEs)
Measured: 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
Measured: in procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitiloop Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chanan Schneider, Study chair, Nitiloop Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358629
- Sponsor's protocol ID
- NT-CPEX-01
- Status last verified
- Sep 2016
- First submitted
- 30 Jan 2015
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO).
- ClinicalTrials.gov ID
- NCT02358629
- Acronym / sponsor ID
- NT-CPEX-01
- Conditions
- Chronic Total Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nitiloop Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective, non-randomized | Experimental | Device: NovaCross™ microcatheteruse 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 |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovaCross™ microcathetersuccessful delivery, crossing, and retrieval of the investigational device as identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography | Device | Prospective, non-randomized |
Primary outcome
Major Adverse Events
Time frame: 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
Time frame: in procedure
Successful femoropopliteal/infra popliteal CTO crossing using the NovaCross™ micro-catheter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
Related trials for Chronic Total Occlusion
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Chronic Total Occlusion of Coronary Artery
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Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
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TRIO CTO (Taiwan Research Initiative on Coronary Total Occlusion)
Chronic Total Occlusion (CTO)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanan Schneider study chair
Nitiloop Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NovaCross™ microcatheter in people with Chronic Total Occlusion, run by Nitiloop Ltd. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016; AzTrials last refreshed its copy on 30 Oct 2026.