Text Size

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

This study is currently recruiting participants.
Verified March 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yangsoo Jang, Yonsei University
ClinicalTrials.gov Identifier:
NCT01563952
First received: March 12, 2012
Last updated: March 26, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • event rate of cardiac death within 12 months [ Time Frame: 12 months after CTO intervention. ] [ Designated as safety issue: No ]
    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:
  • Incidence of MACE after stent implantation. [ Time Frame: 24 months after CTO intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563952

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

Locations
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
Principal Investigator: Yang-Soo Jang, MD.PhD. Severance Hospital
  More Information

No publications provided

Responsible Party: Yangsoo Jang, Professor of cardiology, Yonsei University
ClinicalTrials.gov Identifier: NCT01563952     History of Changes
Other Study ID Numbers: 1-2010-0023
Study First Received: March 12, 2012
Last Updated: March 26, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013