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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

400

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Yonsei University

Investigators

  • 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

October 1, 2010

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

March 27, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2010-0023

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.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe