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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)
IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)
Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)
IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jang, Yang-SooRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Non-IVUS guided endeavor-R group

IVUS guided endeavor-R group

Non-IVUS guided Nobori group

IVUS guided Nobori group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

event rate of cardiac death within 12 months
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.
Incidence of cardiac death, MI, TLR and ST for 9, 12 and 24 months after stent implantation. Binary restenosis, late loss, restenosis %, restenosis type and follow-up MLD on follow-up angiography 1 year after CTO intervention 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.

Full Information

First Posted
March 12, 2012
Last Updated
March 26, 2012
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01563952
Brief Title
Impact of Intravascular Ultrasound(IVUS)-Guided Chronic Total Occlusion Intervention With Drug-eluting Stents
Acronym
CTO
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 Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-IVUS guided endeavor-R group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
IVUS guided endeavor-R group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-IVUS guided Nobori group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
IVUS guided Nobori group
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)
Intervention Description
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 Type
Device
Intervention Name(s)
IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)
Intervention Description
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 Type
Device
Intervention Name(s)
Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)
Intervention Description
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 Type
Device
Intervention Name(s)
IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)
Intervention Description
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.
Primary Outcome Measure Information:
Title
event rate of cardiac death within 12 months
Description
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
Time Frame
12 months after CTO intervention.
Secondary Outcome Measure Information:
Title
Incidence of MACE after stent implantation.
Description
Incidence of cardiac death, MI, TLR and ST for 9, 12 and 24 months after stent implantation. Binary restenosis, late loss, restenosis %, restenosis type and follow-up MLD on follow-up angiography 1 year after CTO intervention 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.
Time Frame
24 months after CTO intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is ≥ 20 years or ≤ 80 years old On coronary angiography, complete obstruction of coronary blood flow (TIMI grade 0) with estimated occlusion duration ≥ 3months. On coronary angiography, Reference vessel diameter of 2.5 to 4.0mm by operator assessment 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. Guide wire can be passed through occluded lesion without complications Patients who can keep the dual antiplatelet treatment (aspirin, clopidogrel) more than 6 months after procedure Exclusion Criteria: Hypersensitivity reaction or side effects to Aspirin, Clopidogrel, Biolimus A9 and Zotarolimus unprotected Left main disease Cardiogenic shock or LV ejection fraction ≤ 30% Previous stent restenotic lesion Treated within 2 weeks at the same lesion. Creatinine level ≥ 2.0 mg/dL or ESRD Severe tortuous and calcified lesion (Unobtainable IVUS image) Life expectancy < 1 year Severe hepatic dysfunction (3 times normal reference values) Pregnant women or women with potential childbearing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang-Soo Jang, MD.PhD.
Phone
+82 2 2228 8445
Email
jangys1212@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang-Soo Jang, MD.PhD.
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jang, Yang-Soo
City
Seoul
State/Province
Seodaemun-gu/Sinchon-dong
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang-Soo Jang, MD.PhD
Phone
+82 2 2228 8445
Email
jangys1212@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Yang-Soo Jang, MD.PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26156151
Citation
Kim BK, Shin DH, Hong MK, Park HS, Rha SW, Mintz GS, Kim JS, Kim JS, Lee SJ, Kim HY, Hong BK, Kang WC, Choi JH, Jang Y; CTO-IVUS Study Investigators. Clinical Impact of Intravascular Ultrasound-Guided Chronic Total Occlusion Intervention With Zotarolimus-Eluting Versus Biolimus-Eluting Stent Implantation: Randomized Study. Circ Cardiovasc Interv. 2015 Jul;8(7):e002592. doi: 10.1161/CIRCINTERVENTIONS.115.002592.
Results Reference
derived

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

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