Impact of Intravascular Ultrasound(IVUS)-Guided Chronic Total Occlusion Intervention With Drug-eluting Stents (CTO)

March 26, 2012 updated by: Yangsoo Jang, Yonsei University

Impact of IVUS-guided Chronic Total Occlusion InterVention With DrUg-eluting Stents on Mid-term Angiographic and Clinical Outcomes (CTO-IVUS Study)

Guidance of stenting by IVUS has been proposed as a method to reduce restenosis rates, because lumen and stent dimensions can be accurately determined by intravascular ultrasound (IVUS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Guidance of stenting by IVUS has been proposed as a method to reduce restenosis rates, because lumen and stent dimensions can be accurately determined by intravascular ultrasound (IVUS). However, randomized studies investigating this strategy have yielded inconsistent results. Therefore, the investigators hypothesized that the potential advantages of IVUS guidance would be most apparent in Chronic Total Occlusion (CTO) intervention and try to evaluate the impact of IVUS-guided chronic total occlusion intervention with drug-eluting stents on mid-term angiographic, IVUS and clinical outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
    • Seodaemun-gu/Sinchon-dong
      • Seoul, Seodaemun-gu/Sinchon-dong, Korea, Republic of, 120-752
        • Recruiting
        • Jang, Yang-Soo
        • Contact:
        • Principal Investigator:
          • Yang-Soo Jang, MD.PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient is ≥ 20 years or ≤ 80 years old
  2. On coronary angiography, complete obstruction of coronary blood flow (TIMI grade 0) with estimated occlusion duration ≥ 3months.
  3. On coronary angiography, Reference vessel diameter of 2.5 to 4.0mm by operator assessment
  4. On coronary angiography, Total length of total occluded lesion and main lesion is less than 80mm and lesions can be treated less than 4 stents.
  5. Guide wire can be passed through occluded lesion without complications
  6. Patients who can keep the dual antiplatelet treatment (aspirin, clopidogrel) more than 6 months after procedure

Exclusion Criteria:

  1. Hypersensitivity reaction or side effects to Aspirin, Clopidogrel, Biolimus A9 and Zotarolimus
  2. unprotected Left main disease
  3. Cardiogenic shock or LV ejection fraction ≤ 30%
  4. Previous stent restenotic lesion
  5. Treated within 2 weeks at the same lesion.
  6. Creatinine level ≥ 2.0 mg/dL or ESRD
  7. Severe tortuous and calcified lesion (Unobtainable IVUS image)
  8. Life expectancy < 1 year
  9. Severe hepatic dysfunction (3 times normal reference values)
  10. Pregnant women or women with potential childbearing

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Non-IVUS guided endeavor-R group
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
Device: Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
Experimental: IVUS guided endeavor-R group
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
Device: IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
Active Comparator: Non-IVUS guided Nobori group
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
Device: Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
Experimental: IVUS guided Nobori group
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
Device: IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)
2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
event rate of cardiac death within 12 months
Time Frame: 12 months after CTO intervention.
Between IVUS guided intervention and non-IVUS guided intervention in patient with chronic total occlusion, the difference of post-procedural success rate, the combined event rate of cardiac death, MI and target lesion revascularization within 12 months. And incidence of composite events in cross over case of IVUS duing CTO intervention
12 months after CTO intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of MACE after stent implantation.
Time Frame: 24 months after CTO intervention
  1. Incidence of cardiac death, MI, TLR and ST for 9, 12 and 24 months after stent implantation.
  2. Binary restenosis, late loss, restenosis %, restenosis type and follow-up MLD on follow-up angiography 1 year after CTO intervention

  3. Subgroup analysis; : Among the IVUS guided intervention group, Non-IVUS giuded intervention group and total patient group,

    • To analyse difference of clinical outcome and angiographical outcome between Endeavor Resolute and Nobori stent.
    • To analyse change of Stenting distal part using IVUS parameters.
24 months after CTO intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yang-Soo Jang, MD.PhD., Severance Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-2010-0023

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