Coronary Artery DiseasePhase 4CTONCT01563952
Impact of Intravascular Ultrasound(IVUS)-Guided Chronic Total Occlusion Intervention With Drug-eluting Stents
A Phase 4 study testing Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic), IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic) and Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo) in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic), IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic) and Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jang, Yang-Soo
Seoul, Seodaemun-gu/Sinchon-dong, 120-752
Yang-Soo Jang, MD.PhD, +82 2 2228 8445, jangys1212@yuhs.ac
Yang-Soo Jang, MD.PhD
About this study
Official title: 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).
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- 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)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)Device
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.
IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)Device
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.
Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)Device
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.
IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-IVUS guided endeavor-R group | Active comparator | 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. Receives: Device: Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic) |
| IVUS guided endeavor-R group | Experimental | 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. Receives: Device: IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic) |
| Non-IVUS guided Nobori group | Active comparator | 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. Receives: Device: Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo) |
| IVUS guided Nobori group | Experimental | 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. Receives: Device: IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months after CTO intervention.
Secondary outcomes (1)
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.
Measured: 24 months after CTO intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startOct 2010
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yangsoo Jang, Yonsei University
- Investigators
- Yang-Soo Jang, MD.PhD., Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563952
- Sponsor's protocol ID
- 1-2010-0023
- Acronym
- CTO
- Status last verified
- Mar 2012
- First submitted
- 12 Mar 2012
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26156151
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of IVUS-guided Chronic Total Occlusion InterVention With DrUg-eluting Stents on Mid-term Angiographic and Clinical Outcomes (CTO-IVUS Study)
- ClinicalTrials.gov ID
- NCT01563952
- Acronym / sponsor ID
- CTO / 1-2010-0023
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-IVUS guided endeavor-R group | Active comparator | 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. |
| IVUS guided endeavor-R group | Experimental | 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. |
| Non-IVUS guided Nobori group | Active comparator | 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. |
| IVUS guided Nobori group | Experimental | 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Non-IVUS guided endeavor-R group |
| 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 endeavor-R group |
| 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 | Non-IVUS guided Nobori group |
| 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 Nobori group |
Primary outcome
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
1 secondary outcome
Incidence of MACE after stent implantation.
Time frame: 24 months after CTO intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
- Derived from this study: PubMed 26156151Kim 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.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang-Soo Jang, MD.PhD. principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic), IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic) and Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo) in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang-Soo Jang, MD.PhD. (+82 2 2228 8445, jangys1212@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event rate of cardiac death within 12 months (time frame: 12 months after CTO intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01563952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2012.