Chronic Total OcclusionCTO-PCINCT03988166
Chronic Total Occlusion Percutaneous Coronary Intervention Study
A study testing Chronic Total Occlusion Revascularization and GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter in people with Chronic Total Occlusion and Ischemic Heart Disease, run by Vascular Solutions LLC at 13 sites in United States.
Trial summary
The objective of this study is to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion, Ischemic Heart Disease, Chronic Total Occlusion of Coronary Artery
- What is being tested?
- Chronic Total Occlusion Revascularization and GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesUnited States
- Study dates
- 20 May 2020to 22 Feb 2021
- Phase
- Interventional
- 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
Who may be able to join
- Participants must meet all of the following inclusion criteria:
- General inclusion criteria
- At least 18 years of age at the time of consent
- Experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization
- Participant is eligible and consents to undergo PCI procedure
- Acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG)
Show all 10Show fewer
- Willing and able to sign a study Informed Consent Form (ICF) approved by a local or central Institutional Review Board (IRB)
- Female participants of childbearing potential must have a negative pregnancy test per standard of care for PCI and be practicing contraception
- Angiographic inclusion criteria
- A minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting the definition of CTO (any non-acute total coronary occlusion fulfilling the angiographic characteristics consistent with high-grade native coronary stenosis (Thrombolysis in Myocardial Infarction (TIMI) score of 0 or 1) and estimated to be in duration of ≥ 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram)
Who cannot join
- Participants must not meet any of the following exclusion criteria:
- General exclusion criteria
- History of allergy to iodinated contrast that cannot be effectively managed medically
- Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment defined as creatine kinase-muscle brain subunits (CK-MB) greater than 3 times the upper limit of normal (ULN)
- Previous coronary interventional procedure of any kind within 30 days prior to the procedure
- Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI (e.g., aspirin, clopidogrel, unfractionated heparin)
Show all 33Show fewer
- Target lesion requires treatment with another device, after successful crossing with a study device, other than PTCA devices prior to stent placement
- Atherectomy procedure is planned for the target lesion
- Known history of clinically significant abnormal laboratory findings ≤ 14 days prior to enrollment, including:
- Neutropenia (<1000 neutrophils/mm^3)
- Thrombocytopenia (<100,000 platelets/mm^3)
- Aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase, or bilirubin > 1.5 × ULN
- Serum creatinine >2.0 mg/dL
- Evidence of current clinical instability including the following:
- Sustained systolic blood pressure <100 mmHg or cardiogenic shock
- Acute pulmonary edema or severe congestive heart failure (CHF). Severe CHF is defined as New York Heart Association (NYHA) Class IV
- Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
- Suspected dissecting aortic aneurysm
- Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
- History of stroke or transient ischemic attack within 6 months prior to procedure
- Active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to procedure
- History of bleeding diathesis or coagulopathy or refusal of blood transfusions
- Other pathology such as cancer, known mental illness, etc., which might, in the opinion of the Investigator, put the patient at risk or confound the results of the study
- Unable or unwilling to comply with the protocol
- Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound, or other coronary artery imaging procedures
- Angiographic exclusion criteria
- Occlusion involves segment within previous stent ("in-stent occlusions")
- Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4)
- Previous stenting (drug-eluting or bare metal) in the target vessel unless the following conditions are met:
- It has been at least 9 months since the previous stenting
- Target lesion is ≥15 mm away from the previously placed stent
- Previously stented segment (stent plus 5 mm on either side) has no more than 40 percent diameter stenosis, based on visual estimate
- Target vessel has other lesions proximal to the total occlusion identified with > 75 percent diameter stenosis based on visual estimate; exception: planned stenting of a lesion proximal to the target lesion that can be covered by a single stent (i.e., tandem lesions) is acceptable
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Emory University
Atlanta, Georgia, 30322
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02214
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
The Christ Hospital
Cincinnati, Ohio, 45219
Missouri Cardiovascular Specialists
Columbia, Missouri, 65201
Henry Ford Hospital
Detroit, Michigan, 48202
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
NYU Langone Health
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
University of Washington
Seattle, Washington, 98195
Torrance Memorial Medical Center
Torrance, California, 90505
About this study
Official title: Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study
The objective of this study is to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used.
Read the detailed description
A prospective, multicenter, single-arm, intent-to-treat, literature-controlled clinical study. The study will be conducted in up to 15 investigational sites in the U.S. This study will enroll up to 150 patients to provide adequate powering for hypothesis testing and an evaluable sample size of at least 135 patients.
The population for this study is participants with signs and/or symptoms considered typical of ischemic heart disease attributed to a de novo CTO in a native coronary artery who are suitable candidates for a percutaneous revascularization.
Study devices include the GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter, and a series of five coronary guidewires (SpectreTM guidewire, R350TM guidewire, RaiderTM guidewire, WarriorTM guidewire, and BanditTM guidewire). All study devices are currently 510(k) cleared for non-CTO indications.
- GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to assist in crossing de novo chronic total occlusions (CTO).
- The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo chronic total occlusions (CTO).
- The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires, to subselectively infuse/deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO). The Teleflex guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
- Conditions
- Chronic Total Occlusion, Ischemic Heart Disease, Chronic Total Occlusion of Coronary Artery
- Being tested
- Chronic Total Occlusion Revascularization, GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter
- Keywords
- Chronic Total Occlusion, Percutaneous revascularization
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Total Occlusion RevascularizationProcedure or surgery
Teleflex's series of study guidewires and catheters will be used to facilitate the safe and effective crossing of de novo CTOs and placement of conventional guidewires beyond the lesion via either a true lumen or subintimal pathway.
GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheterDevice
GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter
| Study group | Role | What they receive |
|---|---|---|
| Chronic Total Occlusion Percutaneous Coronary Intervention | Other | CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used. Receives: Procedure: Chronic Total Occlusion Revascularization; Device: GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Procedure Success
Defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital major adverse cardiac events (MACE).
- MACE defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural myocardial infarction (MI) (Q-wave or non-Q-wave, with creatine kinase (CK) with Muscle (M)-Brain (B) subunits > 3 ULN).
Measured: Through Discharge up to 24 hours post-procedure
Secondary outcomes (5)
Number of Participants With Successful Recanalization.
Defined as angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.
Measured: Through Procedure, up to 4 hours
Number of Participants With In-hospital MACE.
Defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural MI (Q-wave or non-Q-wave, with CK-MB > 3 ULN). The components of MACE will also be reported separately.
Measured: Through Discharge up to 24 hours
Number of Participants With Clinically Significant Perforation.
Defined as any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft, or comparable therapy.
Measured: Through Procedure up to 4 hours
Number of Participants With Procedural Success According to Crossing Technique.
Procedural success is defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital major adverse cardiac events (MACE).
Measured: Through Procedure up to 4 hours post-procedure
Number of Participants With Technical Success.
Defined as successful guidewire recanalization is applicable to investigational devices as at least one investigational guidewire must be used in every procedure.
Measured: Through Procedure up to 4 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start20 May 2020
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- A prospective, multicenter, single-arm, intent-to-treat, literature-controlled clinical study.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Solutions LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teleflex, Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- David E Kandzari, MD, Principal investigator, Piedmont Heart InstituteDimitrios Karmpaliotis, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988166
- Sponsor's protocol ID
- ST2955
- Acronym
- CTO-PCI
- Status last verified
- Oct 2021
- First submitted
- 13 Jun 2019
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kandzari DE, Alaswad K, Jaffer FA, Brilakis E, Croce K, Kearney K, Spaedy A, Yeh R, Thompson C, Nicholson W, Wyman RM, Riley R, Lansky A, Buller C, Karmpaliotis D. Safety and efficacy of dedicated guidewire, microcatheter, and guide catheter extension technologies for chronic total coronary occlusion revascularization: Primary results of the Teleflex Chronic Total Occlusion Study. Catheter Cardiovasc Interv. 2022 Feb;99(2):263-270. doi: 10.1002/ccd.29962. Epub 2021 Sep 28.
PubMed 34582080
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study
- ClinicalTrials.gov ID
- NCT03988166
- Acronym / sponsor ID
- CTO-PCI / ST2955
- Conditions
- Chronic Total Occlusion, Ischemic Heart Disease, Chronic Total Occlusion of Coronary Artery
- Keywords
- Chronic Total Occlusion, Percutaneous revascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Vascular Solutions LLCIndustry (pharma, biotech, devices)
- Collaborators
- Teleflex, Bright Research Partners
- Study start
- 20 May 2020 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used.
Detailed description
A prospective, multicenter, single-arm, intent-to-treat, literature-controlled clinical study. The study will be conducted in up to 15 investigational sites in the U.S. This study will enroll up to 150 patients to provide adequate powering for hypothesis testing and an evaluable sample size of at least 135 patients.
The population for this study is participants with signs and/or symptoms considered typical of ischemic heart disease attributed to a de novo CTO in a native coronary artery who are suitable candidates for a percutaneous revascularization.
Study devices include the GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter, and a series of five coronary guidewires (SpectreTM guidewire, R350TM guidewire, RaiderTM guidewire, WarriorTM guidewire, and BanditTM guidewire). All study devices are currently 510(k) cleared for non-CTO indications.
- GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to assist in crossing de novo chronic total occlusions (CTO).
- The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo chronic total occlusions (CTO).
- The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires, to subselectively infuse/deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO). The Teleflex guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, multicenter, single-arm, intent-to-treat, literature-controlled clinical study.
| Arm | Type | Receives |
|---|---|---|
| Chronic Total Occlusion Percutaneous Coronary Intervention | Other | Procedure: Chronic Total Occlusion Revascularization, Device: GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheterCTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- General inclusion criteria
- At least 18 years of age at the time of consent
- Experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization
- Participant is eligible and consents to undergo PCI procedure
- Acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG)
Key exclusion criteria (33 listed)
- General exclusion criteria
- History of allergy to iodinated contrast that cannot be effectively managed medically
- Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment defined as creatine kinase-muscle brain subunits (CK-MB) greater than 3 times the upper limit of normal (ULN)
- Previous coronary interventional procedure of any kind within 30 days prior to the procedure
- Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI (e.g., aspirin, clopidogrel, unfractionated heparin)
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 |
|---|---|---|
| Chronic Total Occlusion RevascularizationTeleflex's series of study guidewires and catheters will be used to facilitate the safe and effective crossing of de novo CTOs and placement of conventional guidewires beyond the lesion via either a true lumen or subintimal pathway. | Procedure or surgery | Chronic Total Occlusion Percutaneous Coronary Intervention |
| GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheterGuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter | Device | Chronic Total Occlusion Percutaneous Coronary Intervention |
Primary outcome
Number of Participants With Procedure Success
Time frame: Through Discharge up to 24 hours post-procedure
Defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital major adverse cardiac events (MACE). • MACE defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural myocardial infarction (MI) (Q-wave or non-Q-wave, with creatine kinase (CK) with Muscle (M)-Brain (B) subunits > 3 ULN).
5 secondary outcomes
Number of Participants With Successful Recanalization.
Time frame: Through Procedure, up to 4 hours
Number of Participants With In-hospital MACE.
Time frame: Through Discharge up to 24 hours
Number of Participants With Clinically Significant Perforation.
Time frame: Through Procedure up to 4 hours
Number of Participants With Procedural Success According to Crossing Technique.
Time frame: Through Procedure up to 4 hours post-procedure
Number of Participants With Technical Success.
Time frame: Through Procedure up to 4 hours post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34582080Kandzari DE, Alaswad K, Jaffer FA, Brilakis E, Croce K, Kearney K, Spaedy A, Yeh R, Thompson C, Nicholson W, Wyman RM, Riley R, Lansky A, Buller C, Karmpaliotis D. Safety and efficacy of dedicated guidewire, microcatheter, and guide catheter extension technologies for chronic total coronary occlusion revascularization: Primary results of the Teleflex Chronic Total Occlusion Study. Catheter Cardiovasc Interv. 2022 Feb;99(2):263-270. doi: 10.1002/ccd.29962. Epub 2021 Sep 28.
- 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.
David E Kandzari, MD principal investigator
Piedmont Heart Institute
Dimitrios Karmpaliotis, MD, PhD principal investigator
Columbia University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Total Occlusion Revascularization and GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter in people with Chronic Total Occlusion and Ischemic Heart Disease, run by Vascular Solutions LLC at 13 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 10 inclusion and 33 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 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 28 Sep 2022). 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?
Number of Participants With Procedure Success (time frame: Through Discharge up to 24 hours post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03988166, which also lists 1 linked publication.
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 Sep 2022.