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

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ClinicalTrials.gov Identifier: NCT01563952
Recruitment Status : Unknown
Verified March 2012 by Yangsoo Jang, Yonsei University.
Recruitment status was:  Recruiting
First Posted : March 27, 2012
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
Yangsoo Jang, Yonsei University

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic) Device: IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic) Device: Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo) Device: IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Impact of IVUS-guided Chronic Total Occlusion InterVention With DrUg-eluting Stents on Mid-term Angiographic and Clinical Outcomes (CTO-IVUS Study)
Study Start Date : October 2010
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01563952


Contacts
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Contact: Yang-Soo Jang, MD.PhD. +82 2 2228 8445 jangys1212@yuhs.ac

Locations
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Korea, Republic of
Jang, Yang-Soo Recruiting
Seoul, Seodaemun-gu/Sinchon-dong, Korea, Republic of, 120-752
Contact: Yang-Soo Jang, MD.PhD    +82 2 2228 8445    jangys1212@yuhs.ac   
Principal Investigator: Yang-Soo Jang, MD.PhD         
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Yang-Soo Jang, MD.PhD. Severance Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yangsoo Jang, Professor of cardiology, Yonsei University
ClinicalTrials.gov Identifier: NCT01563952    
Other Study ID Numbers: 1-2010-0023
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Umirolimus
 Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents