Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    cto teleflex
Previous Study | Return to List | Next Study

Chronic Total Occlusion Percutaneous Coronary Intervention Study (CTO-PCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03988166
Recruitment Status : Completed
First Posted : June 17, 2019
Last Update Posted : October 5, 2021
Sponsor:
Collaborators:
Teleflex
Bright Research Partners
Information provided by (Responsible Party):
Vascular Solutions LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Total Occlusion Ischemic Heart Disease Chronic Total Occlusion of Coronary Artery Procedure: Chronic Total Occlusion Revascularization Device: GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective, multicenter, single-arm, intent-to-treat, literature-controlled clinical study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study
Actual Study Start Date : May 20, 2020
Actual Primary Completion Date : February 22, 2021
Actual Study Completion Date : February 22, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Chronic Total Occlusion Percutaneous Coronary Intervention
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used.
Procedure: Chronic Total Occlusion Revascularization
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.

Device: GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter
GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter




Primary Outcome Measures :
  1. Procedure success [ Time Frame: Through Discharge or 24 hours post-procedure, whichever comes first ]

    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 MI (Q-wave or non-Q-wave, with CK-MB > 3 ULN).



Secondary Outcome Measures :
  1. Frequency of successful recanalization [ Time Frame: Through Procedure ]
    Defined as angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.

  2. Frequency of in-hospital MACE [ Time Frame: Through Discharge or 24 hours post-procedure, whichever comes first (in-hospital), and at 30 days post-procedure ]
    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.

  3. Frequency of clinically significant perforation [ Time Frame: Through Procedure ]
    Defined as any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft, or comparable therapy.

  4. Procedural success [ Time Frame: Through Procedure ]
    According to crossing technique.

  5. Technical success [ Time Frame: Through Procedure ]
    Defined as successful guidewire recanalization.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants must meet all of the following inclusion criteria:

General inclusion criteria

  1. At least 18 years of age at the time of consent
  2. 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
  3. Participant is eligible and consents to undergo PCI procedure
  4. Acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency CABG
  5. Willing and able to sign a study Informed Consent Form (ICF) approved by a local or central Institutional Review Board (IRB)
  6. Female participants of childbearing potential must have a negative pregnancy test per standard of care for PCI and be practicing contraception

    Angiographic inclusion criteria

  7. 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)

Exclusion Criteria:

Participants must not meet any of the following exclusion criteria:

General exclusion criteria

  1. History of allergy to iodinated contrast that cannot be effectively managed medically
  2. Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment defined as CK-MB greater than 3 times the upper limit of normal (ULN)
  3. Previous coronary interventional procedure of any kind within 30 days prior to the procedure
  4. 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)
  5. Target lesion requires treatment with another device, after successful crossing with a study device, other than PTCA devices prior to stent placement
  6. Atherectomy procedure is planned for the target lesion
  7. 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)
    • AST, ALT, alkaline phosphatase, or bilirubin > 1.5 × ULN
    • Serum creatinine >2.0 mg/dL
  8. 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 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
  9. History of stroke or transient ischemic attack within 6 months prior to procedure
  10. Active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to procedure
  11. History of bleeding diathesis or coagulopathy or refusal of blood transfusions
  12. 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
  13. Unable or unwilling to comply with the protocol
  14. 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

  15. Occlusion involves segment within previous stent ("in-stent occlusions")
  16. Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4)
  17. 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
  18. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988166


Locations
Layout table for location information
United States, California
Torrance Memorial Medical Center
Torrance, California, United States, 90505
United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Missouri Cardiovascular Specialists
Columbia, Missouri, United States, 65201
United States, New York
NYU Langone Health
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Vascular Solutions LLC
Teleflex
Bright Research Partners
Investigators
Layout table for investigator information
Principal Investigator: David E Kandzari, MD Piedmont Heart Institute
Principal Investigator: Dimitrios Karmpaliotis, MD, PhD Columbia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Vascular Solutions LLC
ClinicalTrials.gov Identifier: NCT03988166    
Other Study ID Numbers: ST2955
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Vascular Solutions LLC:
Chronic Total Occlusion
Percutaneous revascularization
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases