Chronic Total OcclusionNCT04862559
A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions
A study testing NovaCross in people with Chronic Total Occlusion, run by Nitiloop Ltd. at 1 site in Poland.
Trial summary
This is an open label, single-center, prospective, pivotal study in which the investigational device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo CTO-PCI using an anterograde approach. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2017to 17 Sep 2017
- 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 is a suitable candidate for non-emergent, coronary angioplasty
- Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration either by documentation or PI assessment Investigator) showing distal TIMI flow 0.
- Coronary angiography of CTO lesion reveals satisfactory distal vessel visualization
- CTO lesion is located in a coronary vessel with a reference diameter of at least 2 millimeters.
Show all 9Show fewer
- CTO lesion is suitable for antegrade approach.
- Left ventricle ejection fraction > 25%
- Body Mass Index (BMI) < 40
Who cannot join
- Patient unable to give informed consent.
- Patient is participating in another study with any investigational drug or device.
- Patient is known or suspected not to tolerate the contrast agent.
- Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO.
- Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
- Appearance of a fresh thrombus or intraluminal filling defects.
Show all 12Show fewer
- Recent major cerebrovascular event (stroke or TIA within 30 days)
- Significant anemia (hemoglobin < 8.0 mg / dl)
- Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
- Recent myocardial infarction (MI) (within the past two weeks)
- Unwillingness or inability to comply with any protocol requirements
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Center, Non-randomized, Single Arm, Open Label, Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
This is an open label, single-center, prospective, pivotal study in which the investigational device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo CTO-PCI using an anterograde approach.
- Conditions
- Chronic Total Occlusion
- Being tested
- NovaCross
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaCrossDevice
A device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions
| Study group | Role | What they receive |
|---|---|---|
| NovaCross | Experimental | Subjects in this arm are treated with the investigational device, NovaCross micro-cetheter, to facilitate the opening of a chronic total occlusion (CTO) Receives: Device: NovaCross |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Adverse Events (Primary Safety)
Accumulative incidence of Major Adverse Cardiovascular Events (MACE), defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).
Measured: 30 days
Technical Success (Primary Efficacy)
Intra-procedural technical success, defined as the ability of the NovaCross™ microcatheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion in the true vessel lumen
Measured: 1 day
Secondary outcomes (6)
Procedural Success
The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow
Measured: 1 day
Assistance in Guidewire Penetration
The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO
Measured: 1 day
Crossability
The effectiveness of the extendable portion in intra-CTO microcatheter crossability
Measured: 1 day
Procedual Visualization
The ability to have full visualization of the NovaCross during the CTO procedure
Measured: 1 day
Operator Ease of Use
Assess the usability of the NovaCross™ by the operator
Measured: 1 day
Device Related Perforation Rate
Device-related perforation at the site of target coronary lesion and/or its proximal reference segment
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Feb 2017
- Primary completion17 Sep 2017
- Study completion17 Sep 2017
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitiloop Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chanan Schneider, Mr., Study director, Company Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862559
- Sponsor's protocol ID
- NT-CLP-02
- Status last verified
- Sep 2016
- First submitted
- 23 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Non-randomized, Single Arm, Open Label, Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
- ClinicalTrials.gov ID
- NCT04862559
- Acronym / sponsor ID
- NT-CLP-02
- Conditions
- Chronic Total Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nitiloop Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 17 Sep 2017 (actual)
- Study completion
- 17 Sep 2017 (actual)
- First posted
- 28 Apr 2021 (actual)
- 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.
This is an open label, single-center, prospective, pivotal study in which the investigational device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo CTO-PCI using 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 |
|---|---|---|
| NovaCross | Experimental | Device: NovaCrossSubjects in this arm are treated with the investigational device, NovaCross micro-cetheter, to facilitate the opening of a chronic total occlusion (CTO) |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult aged 25-80
- Patient understands and has signed the study informed consent form.
- Patient is a suitable candidate for non-emergent, coronary angioplasty
- Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration either by documentation or PI assessment Investigator) showing distal TIMI flow 0.
- Coronary angiography of CTO lesion reveals satisfactory distal vessel visualization
Key exclusion criteria (12 listed)
- Patient unable to give informed consent.
- Patient is participating in another study with any investigational drug or device.
- Patient is known or suspected not to tolerate the contrast agent.
- Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO.
- Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
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 |
|---|---|---|
| NovaCrossA device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions | Device | NovaCross |
Primary outcome
Cardiovascular Adverse Events (Primary Safety)
Time frame: 30 days
Accumulative incidence of Major Adverse Cardiovascular Events (MACE), defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).
Technical Success (Primary Efficacy)
Time frame: 1 day
Intra-procedural technical success, defined as the ability of the NovaCross™ microcatheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion in the true vessel lumen
6 secondary outcomes
Procedural Success
Time frame: 1 day
Assistance in Guidewire Penetration
Time frame: 1 day
Crossability
Time frame: 1 day
Procedual Visualization
Time frame: 1 day
Operator Ease of Use
Time frame: 1 day
Device Related Perforation Rate
Time frame: 1 day
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 28 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Total Occlusion
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Not yet recruitingObservational study
Relationship Between Frontal QRS-T Angle and Collateral Circulation in Coronary Artery Chronic Total Occlusion
Chronic Total Occlusion (CTO), Frontal QRS-T Angle
Active, not recruiting
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
Chronic Total Occlusion of Coronary Artery
RecruitingObservational study
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
RecruitingObservational study
Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE)
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, Mr. study director
Company Employee
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 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 9 inclusion and 12 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 28 Apr 2021. 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?
Cardiovascular Adverse Events (Primary Safety) (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 28 Apr 2021.