Chronic Total Occlusion Percutaneous Coronary Intervention Study

NCT03988166 | Completed Results FDA Device

• 1 other identifier: ST2955
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 13

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.

Conditions

Chronic Total Occlusion; Ischemic Heart Disease; Chronic Total Occlusion of Coronary Artery

Keywords

Chronic Total Occlusion; Percutaneous revascularization

Outcome Measures

Primary Outcomes (1)

• 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).

  Through Discharge up to 24 hours post-procedure

Secondary Outcomes (5)

• Number of Participants With Successful Recanalization.

  Through Procedure, up to 4 hours

• Number of Participants With In-hospital MACE.

  Through Discharge up to 24 hours

• Number of Participants With Clinically Significant Perforation.

  Through Procedure up to 4 hours

• Number of Participants With Procedural Success According to Crossing Technique.

  Through Procedure up to 4 hours post-procedure

• Number of Participants With Technical Success.

  Through Procedure up to 4 hours post-procedure

Study Arms (1)

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.

Procedure: Chronic Total Occlusion Revascularization; Device: GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter

Interventions

Chronic Total Occlusion Revascularization PROCEDURE

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.

Chronic Total Occlusion Percutaneous Coronary Intervention

GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter DEVICE

GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter

Chronic Total Occlusion Percutaneous Coronary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Vascular Solutions LLC: lead
• Teleflex: collaborator
• Bright Research Partners: collaborator

Study Sites (13)

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Missouri Cardiovascular Specialists

Columbia, Missouri, 65201, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 34582080 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Ricardo De Medeiros, Director Scientific Clinical Affairs
• Organization: Teleflex

ricardo.demedeiros@teleflex.com

612.812.5008

Study Officials

• David E Kandzari, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

• Dimitrios Karmpaliotis, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, multicenter, single-arm, intent-to-treat, literature-controlled clinical study.

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 17, 2019
• Study Start: May 20, 2020
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)