Coronary OcclusionNCT03719014
Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
A study testing NovaCross in people with Coronary Occlusion, run by Nitiloop Ltd. at 3 sites in United States.
Trial summary
A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Coronary 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
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2018to Dec 2019
- 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 an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0, with a reference diameter of at least 2 millimeters.
- Left ventricle ejection fraction > 25%
Who cannot join
- Patient unable to give informed consent.
- Elevated CK-MB or troponin at baseline
- Patient is known or suspected not to tolerate the contrast agent
- Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion
- Appearance of a fresh thrombus or intraluminal filling defects
- Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor)
Show all 12Show fewer
- Cardiac intervention within 4 weeks of the procedure
- Severe renal insufficiency with eGFR<30 ml/min/1.72 m2
- Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV
- Life expectancy < 2 years due to other illnesses
- Acute or unstable medical disorder/disease that may cause a risk to patient, including:
- Recent myocardial infarction (MI) (within the past two weeks) ii. Significant anemia (e.g. hemoglobin < 8.0 mg / dl) iii. Recent major cerebrovascular event (history of stroke or TIA within 1 month) iv. Severe uncontrolled systemic hypertension (e.g., >180/100 mmHg) v. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Little Rock Medical Center
Little Rock, Arkansas, 72205
Kristin Miller, 501-257-5893, kristin.miller@va.gov
Barry Uretsky, MD
Nyph/Cumc
New York, New York, 10032
Kate Dalton, keb2114@cumc.columbia.edu
Dimitrios Kermpaliotis, MD
York Hospital
York, Pennsylvania, 17403
Sarah Lake, 717-851-5153, slake@wellspan.org
William Nicholson, MD
About this study
Official title: A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
- Conditions
- Coronary Occlusion
- Being tested
- NovaCross
- Medical subject headings
- Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaCrossDevice
The NovaCross micro-catheter will be used during a standard of care Percutanous Coronary Intervention (PCI) on subjects diagnosed with at least one coronary chronic total occlusion (CTO), in order to assist the operator in guidewire stability and centralization.
| Study group | Role | What they receive |
|---|---|---|
| NovaCross | Experimental | the NovaCross is a guidewire positioning and support micro-catheter for improving chronic total occlusion (CTO) crossability. The NovaCross gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extandable segment, both at its distal tip. Receives: Device: NovaCross |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Measure - Rate of in-hospital MACE events
Defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).
Measured: up to 30 days
Primary Outcome Measure - Intra-procedural technical succees
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 (CTO) in the true vessel lumen
Measured: Intra-procedure
Secondary outcomes (5)
Outcome Measure - Rate of procedure 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: Procedure
Outcome Measure - Technical adaptation of the Micro-catheter to the guidewire
The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO
Measured: Procedure
Outcome Measure - Effective micro-catheter crossability
The effectiveness of the extendable portion in intra-CTO microcatheter crossability
Measured: Procedure
Outcome Measure - Ease of Use
Operator's ability to visualize the NoveCross micro-catheter throughout the procedure, as well as to assess the ease of use of the NovaCross
Measured: Procedure
Safety Measure - Myocardial Infraction (MI) rate
Rate of MI events, as defined according to the SCAI and 3rd universal definitions.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Model description
- This is an open label, multi-center, prospective, supplemental study in which the device, NovaCross™ CTO micro-catheter, will be tested in up to 60 patients scheduled to undergo CTO-PCI using an anterograde approach
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nitiloop Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Walsh, MD, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719014
- Sponsor's protocol ID
- NT-CLP-01 Cohort B
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
- ClinicalTrials.gov ID
- NCT03719014
- Acronym / sponsor ID
- NT-CLP-01 Cohort B
- Conditions
- Coronary Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nitiloop Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 25 Oct 2018 (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.
A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label, multi-center, prospective, supplemental study in which the device, NovaCross™ CTO micro-catheter, will be tested in up to 60 patients scheduled to undergo CTO-PCI using an anterograde approach
| Arm | Type | Receives |
|---|---|---|
| NovaCross | Experimental | Device: NovaCrossthe NovaCross is a guidewire positioning and support micro-catheter for improving chronic total occlusion (CTO) crossability. The NovaCross gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extandable segment, both at its distal tip. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult aged 25-80
- Patient understands and has signed the study informed consent form
- Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0, with a reference diameter of at least 2 millimeters.
- Left ventricle ejection fraction > 25%
Key exclusion criteria (12 listed)
- Patient unable to give informed consent.
- Elevated CK-MB or troponin at baseline
- Patient is known or suspected not to tolerate the contrast agent
- Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion
- Appearance of a fresh thrombus or intraluminal filling defects
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 |
|---|---|---|
| NovaCrossThe NovaCross micro-catheter will be used during a standard of care Percutanous Coronary Intervention (PCI) on subjects diagnosed with at least one coronary chronic total occlusion (CTO), in order to assist the operator in guidewire stability and centralization. | Device | NovaCross |
Primary outcome
Primary Safety Measure - Rate of in-hospital MACE events
Time frame: up to 30 days
Defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).
Primary Outcome Measure - Intra-procedural technical succees
Time frame: Intra-procedure
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 (CTO) in the true vessel lumen
5 secondary outcomes
Outcome Measure - Rate of procedure success
Time frame: Procedure
Outcome Measure - Technical adaptation of the Micro-catheter to the guidewire
Time frame: Procedure
Outcome Measure - Effective micro-catheter crossability
Time frame: Procedure
Outcome Measure - Ease of Use
Time frame: Procedure
Safety Measure - Myocardial Infraction (MI) rate
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Simon Walsh, MD principal investigator
Belfast Health and Social Care Trust
3 sites 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 Coronary Occlusion, run by Nitiloop Ltd. at 3 sites in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maya Shick (+972523355442, maya@nitiloop.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Measure - Rate of in-hospital MACE events (time frame: up to 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 6 Nov 2018.