The Asahi Intecc PTCA Chronic Total Occlusion Study (CTO-PCI)

June 19, 2018 updated by: Asahi Intecc USA Inc

The primary objective of this trial is to evaluate confirmation of placement of any guidewire beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in which at least one Asahi series of guidewires and/or Corsair microcatheter were used.

Procedure success will be 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, multi-center, single-arm, intent-to-treat (ITT) study is designed to assess the safety and effectiveness of the investigational products for the treatment of CTOs in a native coronary artery.

The primary objective of this trial is to evaluate confirmation of placement of any guidewire beyond the CTO in the true vessel lumen in patients in which at least one Asahi series of guidewires and/or Corsair microcatheter were used.

The population for this study is subjects with signs and/or symptoms considered typical of ischemic heart disease attributed to a CTO in a native coronary artery, who are suitable for a percutaneous revascularization.

Procedure success will be 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). All subjects are followed through hospital discharge.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner - University Medical Center Phoenix
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Healthcare
    • Illinois
      • Oakbrook Terrace, Illinois, United States, 60181
        • Advocate Health and Hospitals Corp.
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center/New York Presbyterian Hospital
      • New York, New York, United States, 00029
        • Mount Sinai Hospital
    • Oregon
      • Springfield, Oregon, United States, 97477
        • PeaceHealth Sacred Heart Medical Center
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • York Hospital
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • General Inclusion Criteria:

    1. Subject is ≥ 18 years of age at the time of consent
    2. Subject is experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure, etc.) 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. Subject is eligible and consents to undergo PCI procedure
    4. Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG)
    5. Subject is willing and able to sign an Informed Consent Form approved by a local Institutional Review Board

    6. Female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before the study procedure

      Angiographic Inclusion Criteria:

    7. A minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting definition of chronic total occlusion. Non-study lesions will be treated first. A "chronic total occlusion" is any non-acute total coronary occlusion fulfilling the angiographic characteristics consistent with high-grade native coronary stenosis (TIMI 0) and estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram. An attempt to cross the target lesion with at least one Asahi guidewire or a Corsair microcatheter must be made.

Exclusion Criteria:

  • General Exclusion Criteria:

    1. Subjects with any history of allergy to iodinated contrast that cannot be effectively managed medically
    2. Evidence of acute Myocardial Infarction (MI) within 72 hours of the intended treatment defined as cardiac enzymes greater than Upper Limit of Normal (ULN).
    3. Previous coronary interventional procedure of any kind within the 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, etc.)
    5. Target lesion requires treatment with a device after successful crossing other than PTCA prior to stent placement

    6. Subjects with known history of clinically significant abnormal laboratory findings including:

      • Neutropenia (<1000 neutrophils/mm3) within the previous 2 weeks
      • Thrombocytopenia (<100,000 platelets/mm3)
      • AST, ALT, alkaline phosphatase, or bilirubin > 1.5 × ULN
      • Serum creatinine > 2.0 mg/dL

    7. Subjects with evidence of ongoing or active clinical instability including the following:

      • Sustained systolic blood pressure < 100 mmHg or cardiogenic shock
      • Acute pulmonary edema or severe congestive heart failure
      • 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
    8. History of stroke or transient ischemic attack within the prior 6 months
    9. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
    10. History of bleeding diathesis or coagulopathy or refusal of blood transfusions
    11. Subjects with any other pathology such as cancer, mental illness, etc., which in the opinion of the Investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study
    12. Known previous medical condition yielding expected survival less than 1 year
    13. Subjects who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements

    14. Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints;

      Angiographic Exclusion Criteria:

    15. Occlusion involves segment within previous stent
    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
      • That target lesion is at least 15 mm away from the previously placed stent
      • The previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis, based on visual estimate
    18. The target vessel has other lesions proximal to the total occlusion identified with greater than 75% diameter stenosis based on visual estimate. However, planned stenting of the lesion in target vessel which is proximal to the target lesion and can be covered by a single stent (i.e., tandem lesions) are acceptable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Crossing of Coronary Artery CTO
This is a single arm intent to treat study. A subject is considered enrolled when the subject has given informed consent and meets all inclusion and exclusion criteria, including angiographic inclusion and exclusion criteria, which includes an attempt to cross the target lesion with an investigational device (ASAHI PTCA Guidewire or ASAHI Corsair Microcatheter). Clinical evaluation up to hospital discharge is conducted on all enrolled subjects. The purpose of the clinical follow-up is to determine if the subject has experienced or is experiencing any adverse events
Device: Crossing of Coronary Artery CTO

Standard angiographic procedures will be followed for this study. The primary objective of this trial is to evaluate confirmation of placement of any guidewire beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in which at least one Asahi series of guidewires and/or Corsair microcatheter were used.

Procedure success will be 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 MACE.

Other Name: ASAHI Corsair Microcatheter, ASAHI PTCA Guide Wires

Other Names:
  • Corsair, Gaia, Asahi Guide Wires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Success
Time Frame: Through hospital discharge, typically 24 hours post procedure
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 MACE.
Through hospital discharge, typically 24 hours post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Successful Recanalization
Time Frame: During Procedure
Angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.
During Procedure
Frequency of In-hospital MACE
Time Frame: Up to hospital discharge
Any serious adverse experience that includes cardiac death; target lesion revascularization; or post-procedural MI.
Up to hospital discharge
Frequency of Perforation
Time Frame: During Procedure
Frequency of perforation during the procedure.
During Procedure
Frequency of Dissection
Time Frame: During procedure
Frequency of dissection reported during the procedure
During procedure
Mean Procedural Time
Time Frame: During Procedure
The length of the procedure (The first successful insertion of the guide catheter at an arteriotomy site is considered the start of the procedure. A procedure is considered complete once the guide catheter is removed from the arteriotomy site.)
During Procedure
Mean Contrast Volume
Time Frame: During Procedure
Volume of contrast administered during procedure
During Procedure
Mean Absorbed Radiation Dose in mGy
Time Frame: During Procedure
Absorbed radiation dose in mGy during procedure
During Procedure
Procedural Success (Evaluated According to Crossing Technique)
Time Frame: Through hospital discharge
The percentage of subjects with procedure success according to crossing technique
Through hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asahi Intecc USA Inc

Collaborators

Medpace, Inc.

Investigators

  • Principal Investigator: Aaron Grantham, MD, MidAmerica Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIUCT-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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