Coronary OcclusionPhase 3Cora CTONCT05848232
Single-Arm Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions
A Phase 3 study testing coraFlex Catheter, coraForce Catheter and coraCross Catheter in people with Coronary Occlusion, run by ReFlow Medical, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the safety and effectiveness of the coraFlex, coraForce, and coraCross catheters for crossing chronic total occlusions of the coronary arteries. The study will compare the rate of procedure success to success rates from previous trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Occlusion
- What is being tested?
- coraFlex Catheter, coraForce Catheter and coraCross Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2024to Feb 2025
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-Procedure Inclusion Criteria:
- Subject willing and able to provide informed consent and able to comply with the study protocol and follow up.
- Male or non-pregnant female ≥18 years of age at time of consent.
- Subjects experiencing clinical symptoms suggestive of ischemic heart disease or has evidence of myocardial ischemia attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization.
- Subject is a candidate for PTCA, stenting, and emergency CABG.
- Angiographic Inclusion Criteria:
- A minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting CTO criteria {defined as TIMI grade 0 flow} and estimated to be > 3 months duration by clinical history and/or comparison with a prior angiogram or electrocardiogram.
Who cannot join
- Pre-procedure Exclusion Criteria:
- Subject unwilling or unable to comply with the protocol or follow-up requirements, in the opinion of the investigator.
- Subject life expectancy less than one year, in the opinion of the investigator.
- Subject is pregnant or planning to become pregnant during the course of the trial.
- Evidence of MI within 72 hours prior to the index procedure.
- History of stroke or transient ischemic attack within 6 months prior to the index procedure.
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- Prior coronary interventional procedure (including coronary artery bypass graft surgery) of any kind within 30 days of the index procedure.
- Inability to tolerate DAPT with aspirin plus a P2Y12 inhibitor.
- Known allergies or sensitivities to heparin, antiplatelet drugs, or other anticoagulant therapies, which could not be substituted, including history of major bleeding event in the last 6 months.
- Allergy or sensitivity to contrast media that cannot be adequately pre-treated prior to the index procedure.
- Subjects with known history of clinically significant abnormal laboratory findings ≤30 days prior to enrollment including:
- Neutropenia (<1000 neutrophils/mm3)
- Thrombocytopenia (<100,000 platelets/mm3)
- AST, ALT, ALP, or bilirubin > 1.5 times ULN
- Serum creatinine > 2.0 mg/dL
- Subject has signs/symptoms of systemic infection/sepsis (temperature ≥ 38.00 Celsius and WBC ≥12,000 cells/µL). If subject has localized infection or infection is adequately treated and controlled, per investigator discretion, patient may be enrolled.
- Evidence of current clinical instability including:
- Sustained systolic blood pressure <100 mmHg or cardiogenic shock
- Acute pulmonary edema or severe congestive heart failure (NYHA class IV)
- Known or suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
- Known or suspected dissecting aortic aneurysm
- Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease.
- Requires mechanical circulatory support (e.g., Impella) during index procedure
- Subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.
- Any concurrent, medical, psychological, or social condition which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
- Angiographic Exclusion Criteria:
- Target lesion is located within a stent (in-stent occlusion).
- Target vessel has other lesions proximal to the total occlusion with >75% stenosis (based on visual estimate) unless there is planned stenting of the proximal lesion as well.
- Angiography demonstrates extensive lesion related thrombus (TIMI thrombus grade 3 or 4).
- Fractured stents in the target vessel.
Trial locations and contacts
1 site in 1 country.
Vicky Joshi contact
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
Lorenzo Azzalini, MD, 206-685-9955
About this study
Official title: A Prospective Single-Arm Multicenter Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions
The goal of this clinical trial is to evaluate the safety and effectiveness of the coraFlex, coraForce, and coraCross catheters for crossing chronic total occlusions of the coronary arteries. The study will compare the rate of procedure success to success rates from previous trials.
Participants will undergo percutaneous coronary intervention (PCI) for a chronic total occlusion and be followed for 30 days post-procedure.
Read the detailed description
The primary objective of this prospective, multicenter, single arm clinical study is to compare the rate of procedure success of the coraCross, coraForce, and coraFlex catheters in facilitating guidewire placement beyond coronary chronic total occlusions to a pre-defined performance goal based on literature. The study population will consist of those 18 years or older with symptomatic ischemic heart disease, undergoing clinically indicated percutaneous recanalization of an occlusive coronary lesion, and meeting all other eligibility criteria. Measures will be assessed through 30 days post-intervention.
- Conditions
- Coronary Occlusion
- Being tested
- coraFlex Catheter, coraForce Catheter, coraCross Catheter
- Medical subject headings
- Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coraFlex CatheterDevice
The coraFlex catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.
coraForce CatheterDevice
The coraForce catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.
coraCross CatheterDevice
The coraCross catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.
| Study group | Role | What they receive |
|---|---|---|
| coraFlex, coraForce, and/or coraCross Catheters | Experimental | Single arm Receives: Device: coraFlex Catheter; Device: coraForce Catheter; Device: coraCross Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success defined as technical success and the absence of in-hospital Major Adverse Cardiovascular Events (MACE)
- Technical success is defined as angiographic confirmation of chronic total occlusion crossing with guidewire placement, facilitated by one or more of the Cora Catheters, in the target vessel true lumen either distal or proximal to the occlusion, depending on the route of access.
- MACE includes cardiac death, myocardial infarction {Q-wave or non-Q-wave, with CK-MB >3 times upper limit of normal}, and target lesion revascularization
Measured: Through hospital discharge or 24 hours post-procedure (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study startJun 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReFlow Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Azzalini, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848232
- Sponsor's protocol ID
- CP-009
- Acronym
- Cora CTO
- Status last verified
- Nov 2023
- First submitted
- 27 Apr 2023
- Last updated
- 10 May 2024
- Results posted
- 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Arm Multicenter Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions
- ClinicalTrials.gov ID
- NCT05848232
- Acronym / sponsor ID
- Cora CTO / CP-009
- Conditions
- Coronary Occlusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- ReFlow Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 8 May 2023 (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.
The goal of this clinical trial is to evaluate the safety and effectiveness of the coraFlex, coraForce, and coraCross catheters for crossing chronic total occlusions of the coronary arteries. The study will compare the rate of procedure success to success rates from previous trials.
Participants will undergo percutaneous coronary intervention (PCI) for a chronic total occlusion and be followed for 30 days post-procedure.
Detailed description
The primary objective of this prospective, multicenter, single arm clinical study is to compare the rate of procedure success of the coraCross, coraForce, and coraFlex catheters in facilitating guidewire placement beyond coronary chronic total occlusions to a pre-defined performance goal based on literature. The study population will consist of those 18 years or older with symptomatic ischemic heart disease, undergoing clinically indicated percutaneous recanalization of an occlusive coronary lesion, and meeting all other eligibility criteria. Measures will be assessed through 30 days post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coraFlex, coraForce, and/or coraCross Catheters | Experimental | Device: coraFlex Catheter, Device: coraForce Catheter, Device: coraCross CatheterSingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pre-Procedure Inclusion Criteria:
- Angiographic Inclusion Criteria:
Key exclusion criteria (30 listed)
- Pre-procedure Exclusion Criteria:
- Angiographic Exclusion Criteria:
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 |
|---|---|---|
| coraFlex CatheterThe coraFlex catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions. | Device | coraFlex, coraForce, and/or coraCross Catheters |
| coraForce CatheterThe coraForce catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions. | Device | coraFlex, coraForce, and/or coraCross Catheters |
| coraCross CatheterThe coraCross catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions. | Device | coraFlex, coraForce, and/or coraCross Catheters |
Primary outcome
Procedure success defined as technical success and the absence of in-hospital Major Adverse Cardiovascular Events (MACE)
Time frame: Through hospital discharge or 24 hours post-procedure (whichever comes first)
* Technical success is defined as angiographic confirmation of chronic total occlusion crossing with guidewire placement, facilitated by one or more of the Cora Catheters, in the target vessel true lumen either distal or proximal to the occlusion, depending on the route of access. * MACE includes cardiac death, myocardial infarction {Q-wave or non-Q-wave, with CK-MB >3 times upper limit of normal}, and target lesion revascularization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- 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.
Vicky Joshi contact
Lorenzo Azzalini, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing coraFlex Catheter, coraForce Catheter and coraCross Catheter in people with Coronary Occlusion, run by ReFlow Medical, Inc. at 1 site 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 7 inclusion and 30 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 10 May 2024. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sara Finton (616-633-9178, sfinton@reflowmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success defined as technical success and the absence of in-hospital Major Adverse Cardiovascular Events (MACE) (time frame: Through hospital discharge or 24 hours post-procedure (whichever comes first)). 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 10 May 2024.