Coronary Artery DiseaseNCT02339545
Coronary Flow Reserve Following Orbital Atherectomy
An observational study of Coronary Artery Disease, run by Abbott Medical Devices at 3 sites in United States.
Trial summary
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary Orbital Atherectomy plus Stenting
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2015to May 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patients who have been determined by their physician to require endovascular intervention for treatment of their CAD.
Who may be able to join
- Subjects must be at least 18 years of age.
- Subjects must be scheduled for percutaneous coronary intervention involving stent deployment in de novo coronary lesions.
- The target vessel must be a de-novo coronary artery with a severely calcified lesion.
- The target vessel reference diameter must be ≥ 2.0mm and ≤ 4.0 mm.
- The lesion length must not exceed 40 mm.
- The target vessel must have a thrombolysis in myocardial infarction (TIMI) flow 3 at baseline.
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- The target lesion must have fluoroscopic, intravascular ultrasound (IVUS) or optical coherence tomograph (OCT) evidence of severe calcium deposit at the lesion site based on the protocol definition.
- The lesion must be crossable with the ViperWire Advance® coronary guide wire.
- Successful revascularization using OAS and stent deployment as demonstrated by no evidence of stent dissection and no more than 50% stenosis proximal to the stent.
Who cannot join
- Inability to understand the study or a history of non-compliance with medical advice.
- Unwilling or unable to sign the informed consent form (ICF).
- History of any cognitive or mental health status that would interfere with study participation.
- Currently enrolled in any pre-approval investigational study. Note: This does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints.
- Female subjects who are pregnant or planning to become pregnant within the study period.
- Previous myocardial infarction of the target vessel.
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- Known sensitivity to contrast media, which cannot be adequately pre-medicated.
- Diagnosed with chronic renal failure or has a serum creatinine level > 2.5 mg/dl.
- History of a stroke or transient ischemic attack (TIA) within six (6) months of the procedure.
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within six (6) months of the procedure.
- Wall motion abnormality in the intended vessel target zone.
- Severe chronic obstructive pulmonary disease (COPD), asthma or current use of the medication: aminophylline.
- 2nd or 3rd degree atrioventricular (AV) block.
- Evidence of current left ventricular ejection fraction (LVEF) ≤45% (where current is defined as the latest LVEF measurement completed within the last 6 months).
- New York Heart Association (NYHA) class III or IV heart failure.
- Previous coronary artery bypass surgery.
- Known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
- Severe aortic stenosis.
- Severe left ventricular hypertrophy.
- Subject with angiographically confirmed evidence of more than 1 lesion requiring intervention.
- Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate or on-line quantitative coronary analysis (QCA).
- Target vessel has angiographically visible or suspected thrombus.
- Target vessel has a stent from previous PCI unless:
- The stent was implanted greater than 30 days prior to the treatment, and
- The stent has no higher than 30% in-stent stenosis, and
- The stent is on a different branch than the target lesion.
- Target vessel is excessively tortuous.
- Target lesion is an ostial location (within 5 mm of ostium) or an unprotected left main lesion.
- Target lesion is a bifurcation.
- Target lesion has a ≥ 1.5 mm side branch.
- Angiographic evidence of a dissection prior to initiation of orbital atherectomy device (OAD).
- Angiographic evidence of MACE during procedure.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Chandler Regional Medical Center and Mercy Gilbert Medical Center
Chandler, Arizona, 85224
Mercy Hospital
Coon Rapids, Minnesota, 55433
St. Francis Hospital
Roslyn, New York, 11576
About this study
Official title: Coronary Flow Reserve Following Orbital Atherectomy and Percutaneous Revascularization in Severely Calcified Coronary Lesions
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.
Read the detailed description
This is an acute, observational, prospective, multi-center clinical study, evaluating coronary flow reserve (CFR) using the Volcano FloWire®. Subjects will be evaluated after treatment with orbital atherectomy and stenting of de-novo severely calcified lesions, due to coronary artery disease.
Subjects who undergo successful revascularization using the Diamondback 360® Coronary Orbital Atherectomy System (OAS) and stenting are eligible for enrollment. Coronary blood flow of enrolled subjects will be measured with the Volcano FloWire®, Doppler velocity data recorded intra-procedurally, and major adverse cardiac events (MACE) assessed at 24 hours or at discharge, whichever is earlier.
Determination of CFR by Doppler flow measurements can assess physiological changes in the distal vascular bed. The primary endpoint of this study will evaluate coronary flow reserve after successful treatment of severely calcified coronary lesions using OAS and stent deployment. The secondary endpoint will measure the occurrence of post-procedural Major Adverse Cardiac Events (MACE), including cardiac death, acute myocardial infarction (Q wave or non-Q wave), and target vessel revascularization.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary Orbital Atherectomy plus Stenting
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Orbital Atherectomy plus StentingDevice
Also called DIAMONDBACK 360® Coronary Orbital Atherectomy System
| Study group | Role | What they receive |
|---|---|---|
| All Enrolled Subjects | All subjects will receive Coronary Flow Reserve (CFR) measurements post successful orbital atherectomy treatment and stenting. Receives: Device: Coronary Orbital Atherectomy plus Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Flow Reserve (CFR)
CFR was measured after successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions. It was calculated from coronary blood flow velocity measurements, which were derived from Doppler-velocity wire data recorded in real time. The CFR formula utilized was APVp/APVb, where APVb is the average peak velocity at baseline and APVp is peak hyperemia.
Measured: Intra-procedurally following successful stent placement. Average procedure time 56 minutes.
Secondary outcomes (1)
Major Adverse Cardiac Events (MACE)
MACE: cardiac death, acute myocardial infarction (Q wave or non-Q wave), or target vessel revascularization.
Measured: At 24 hours or at time of hospital discharge, whichever occurred first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nabil Dib, MD, Principal investigator, Dignity Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339545
- Sponsor's protocol ID
- CLN-0006-P
- Status last verified
- Jul 2023
- First submitted
- 9 Jan 2015
- Last updated
- 18 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Flow Reserve Following Orbital Atherectomy and Percutaneous Revascularization in Severely Calcified Coronary Lesions
- ClinicalTrials.gov ID
- NCT02339545
- Acronym / sponsor ID
- CLN-0006-P
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Jan 2015 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.
Detailed description
This is an acute, observational, prospective, multi-center clinical study, evaluating coronary flow reserve (CFR) using the Volcano FloWire®. Subjects will be evaluated after treatment with orbital atherectomy and stenting of de-novo severely calcified lesions, due to coronary artery disease.
Subjects who undergo successful revascularization using the Diamondback 360® Coronary Orbital Atherectomy System (OAS) and stenting are eligible for enrollment. Coronary blood flow of enrolled subjects will be measured with the Volcano FloWire®, Doppler velocity data recorded intra-procedurally, and major adverse cardiac events (MACE) assessed at 24 hours or at discharge, whichever is earlier.
Determination of CFR by Doppler flow measurements can assess physiological changes in the distal vascular bed. The primary endpoint of this study will evaluate coronary flow reserve after successful treatment of severely calcified coronary lesions using OAS and stent deployment. The secondary endpoint will measure the occurrence of post-procedural Major Adverse Cardiac Events (MACE), including cardiac death, acute myocardial infarction (Q wave or non-Q wave), and target vessel revascularization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Enrolled Subjects | – | Device: Coronary Orbital Atherectomy plus StentingAll subjects will receive Coronary Flow Reserve (CFR) measurements post successful orbital atherectomy treatment and stenting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been determined by their physician to require endovascular intervention for treatment of their CAD.
Key inclusion criteria (9 listed)
- Subjects must be at least 18 years of age.
- Subjects must be scheduled for percutaneous coronary intervention involving stent deployment in de novo coronary lesions.
- The target vessel must be a de-novo coronary artery with a severely calcified lesion.
- The target vessel reference diameter must be ≥ 2.0mm and ≤ 4.0 mm.
- The lesion length must not exceed 40 mm.
Key exclusion criteria (32 listed)
- Inability to understand the study or a history of non-compliance with medical advice.
- Unwilling or unable to sign the informed consent form (ICF).
- History of any cognitive or mental health status that would interfere with study participation.
- Currently enrolled in any pre-approval investigational study. Note: This does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints.
- Female subjects who are pregnant or planning to become pregnant within the study period.
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 |
|---|---|---|
| Coronary Orbital Atherectomy plus StentingAlso: DIAMONDBACK 360® Coronary Orbital Atherectomy System | Device | All Enrolled Subjects |
Primary outcome
Coronary Flow Reserve (CFR)
Time frame: Intra-procedurally following successful stent placement. Average procedure time 56 minutes.
CFR was measured after successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions. It was calculated from coronary blood flow velocity measurements, which were derived from Doppler-velocity wire data recorded in real time. The CFR formula utilized was APVp/APVb, where APVb is the average peak velocity at baseline and APVp is peak hyperemia.
1 secondary outcome
Major Adverse Cardiac Events (MACE)
Time frame: At 24 hours or at time of hospital discharge, whichever occurred first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Coronary Flow Reserve Assessment of Orbital Atherectomy: An Observational Pilot StudyLink provided by the sponsor.
- 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.
Nabil Dib, MD principal investigator
Dignity Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Abbott Medical Devices 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 9 inclusion and 32 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 18 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Coronary Flow Reserve (CFR) (time frame: Intra-procedurally following successful stent placement. Average procedure time 56 minutes.). 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 18 Jul 2023.