Chronic Total Occlusion of Coronary ArteryNCT02477579
A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
A study testing NovaCross in people with Chronic Total Occlusion of Coronary Artery, run by Nitiloop Ltd. at 5 sites in 2 countries.
Trial summary
This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- What is being tested?
- NovaCross
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 17 May 2015to 10 Aug 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 18 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.
- Suitable candidate for non-emergent, coronary angioplasty
- Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches
- Body Mass Index (BMI) < 40
- Left ventricle ejection fraction > 25%
Who cannot join
- Patient unable to give informed consent.
- Current participation in another study with any investigational drug or device.
- Patient is known or suspected not to tolerate the contrast agent.
- Aorta-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent 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.
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- Recent major cerebrovascular event (history of stroke or TIA within 1 month)
- Cardiac intervention within 4 weeks of the procedure
- Renal insufficiency (serum creatinine of > 2.3mg/dl or 203μmol/L)
- Active gastrointestinal bleeding
- Active infection or fever that may be due to infection
- Life expectancy < 2 years due to other illnesses
- Significant anemia (hemoglobin < 8.0 mg / dl)
- Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure)
- Severe electrolyte imbalance
- Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV.
- 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)
- Uncontrolled diabetes >2 serum glucose concentrations of >350 mg/dl within 7 days.
- Unwillingness or inability to comply with any protocol requirements
- Pregnant or nursing
- Extensive prior dissection from a coronary guidewire use
- Drug abuse or alcoholism.
- Patients under custodial care.
- Bleeding diathesis or coagulation disorder;
- Kawasaki's disease or other vasculitis
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
Edward Hospital
Naperville, Illinois, 60540
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
York Hospital
York, Pennsylvania, 17403
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
This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.
Read the detailed description
The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.
- Being tested
- NovaCross
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaCrossDevice
The NovaCross™ is a guidewire positioning and support microcatheter 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 extendable segment, both at its distal tip.
| Study group | Role | What they receive |
|---|---|---|
| NovaCross | Experimental | NovaCross microcatheter will be used. Receives: Device: NovaCross |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
30 day 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
Intra-procedural technical success
Intra-procedural technical success, defined as the ability of the NovaCross™ micro-catheter 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 (6)
1. 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.
- 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
Proximal cap (ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.)
- The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.
Measured: Procedure
Effectiveness of extendable portion (effectiveness of the extendable portion in intra-CTO microcatheter crossability)
- The effectiveness of the extendable portion in intra-CTO microcatheter crossability.
Measured: Procedure
Visualization (ability to have full visualization of the NovaCross during the CTO procedure)
- The ability to have full visualization of the NovaCross during the CTO procedure.
Measured: Procedure
Usability (Assess the usability of the NovaCross™ by the operator)
- Assess the usability of the NovaCross™ by the operator.
Measured: Procedure
Device-related perforation (at the site of target coronary lesion and/or its proximal reference segment)
- Device-related perforation at the site of target coronary lesion and/or its proximal reference segment.
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study start17 May 2015
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies 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
- 145 participants (actual)
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
- NCT02477579
- Sponsor's protocol ID
- NT-CLP-01
- Status last verified
- Aug 2017
- First submitted
- 17 Jun 2015
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. 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
- NCT02477579
- Acronym / sponsor ID
- NT-CLP-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Nitiloop Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2015 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 23 Jun 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.
This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.
Detailed description
The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.
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: NovaCrossNovaCross microcatheter will be used. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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.
- Suitable candidate for non-emergent, coronary angioplasty
- Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches
Key exclusion criteria (26 listed)
- Patient unable to give informed consent.
- Current participation in another study with any investigational drug or device.
- Patient is known or suspected not to tolerate the contrast agent.
- Aorta-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent 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 |
|---|---|---|
| NovaCrossThe NovaCross™ is a guidewire positioning and support microcatheter 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 extendable segment, both at its distal tip. | Device | NovaCross |
Primary outcome
MACE
Time frame: 30 days
30 day MACE, defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).
Intra-procedural technical success
Time frame: Intra-procedure
Intra-procedural technical success, defined as the ability of the NovaCross™ micro-catheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion (CTO) in the true vessel lumen.
6 secondary outcomes
1. 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.
Time frame: Procedure
Proximal cap (ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.)
Time frame: Procedure
Effectiveness of extendable portion (effectiveness of the extendable portion in intra-CTO microcatheter crossability)
Time frame: Procedure
Visualization (ability to have full visualization of the NovaCross during the CTO procedure)
Time frame: Procedure
Usability (Assess the usability of the NovaCross™ by the operator)
Time frame: Procedure
Device-related perforation (at the site of target coronary lesion and/or its proximal reference segment)
Time frame: Procedure
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 17 Aug 2017.
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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
5 sites in 2 countries: 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 of Coronary Artery, run by Nitiloop Ltd. at 5 sites in 2 countries.
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 7 inclusion and 26 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, 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?
MACE (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 17 Aug 2017.