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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Yonsei University.
Recruitment status was  Recruiting
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

March 12, 2012
March 26, 2012
October 2010
October 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01563952 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Impact of Intravascular Ultrasound(IVUS)-Guided Chronic Total Occlusion Intervention With Drug-eluting Stents
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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Coronary Artery Disease
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
    Intervention: Device: Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)
  • 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.
    Intervention: Device: IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)
  • 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.
    Intervention: Device: Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)
  • 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.
    Intervention: Device: IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact: Yang-Soo Jang, MD.PhD. +82 2 2228 8445 jangys1212@yuhs.ac
Korea, Republic of
 
NCT01563952
1-2010-0023
Yes
Yangsoo Jang, Yonsei University
Yonsei University
Not Provided
Principal Investigator: Yang-Soo Jang, MD.PhD. Severance Hospital
Yonsei University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP