Coronary Artery DiseaseNCT01979744
Intravascular ULTrasound Guided Versus Conventional Angiography Guided Strategy to Deploy Zotarolimus and Everolimus Eluting Third Generation Stents in the Long Coronary Artery Lesions: ULTRA-ZET Trial
A study testing IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertion, Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertion and Angiography guided percutaneous coronary angioplasty with Promus element stent implantation in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Although first generation DES reduced instent restenosis, still remained the unsolved problems such as stent thrombosis and restenosis in the era of DES. Second generation DES had been developed to improve the biocompatibility of stent coating focused on polymer compared to first generation DES, so that second… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertion, Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertion and Angiography guided percutaneous coronary angioplasty with Promus element stent implantation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to 31 Oct 2017
- Phase
- Interventional
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 19 years old
- Coronary artery disease and lesions which are candidate for treatment with drug eluting stent according to current clinical practice guidelines
- PCI for lesion(s) which needs a stent of 26mm or more
- Reference diameter from 2.25 to 4.0mm
Who cannot join
- Restenosis lesion
- Reference vessel diameter < 2.25 mm or > 4.0mm
- Primary PCI for STEMI
- Contraindication to anti-platelet agents
- Treated with any DES within 3 months at other vessel
- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752
About this study
Although first generation DES reduced instent restenosis, still remained the unsolved problems such as stent thrombosis and restenosis in the era of DES. Second generation DES had been developed to improve the biocompatibility of stent coating focused on polymer compared to first generation DES, so that second generation stents showed better outcomes compared with first generation DES. On the other hands, in third generation DES, further refinement of DES involved more flexible stent platform. Promus ElementTM (Everolimus eluting stent, Boston Scientific, Nastick, MA) and Resolute Integrity® (Zotarolimus eluting stent, Medtronic Vascular, Santa Rosa, CA) are the third generation drug eluting stents which are designed to increase flexibility. In previous randomized controlled studies, both of these stents have shown at least non-inferior angiographic and clinical outcomes compared to second generation DES. However, there is lack of data about comparison of angiographic and clinical outcomes between Promus ElementTM and Resolute Integrity®.
IVUS is one of the widely used intracoronary imaging devices to provide more reproducible and accurate information about coronary anatomy than angiography in current practice.8 Optimal stent expansion assessed by intravascular ultrasound (IVUS) has been reported as an important factor to prevent stent thrombosis or restenosis.9 Accordingly, there have been many studies to evaluate the procedural or clinical benefit of IVUS guided angioplasty. However, The clinical benefit of IVUS-guided angioplasty with stent implantation is still in a controversy. In the previous studies, IVUS-guided stent implantation showed positive or negative beneficial effect on clinical outcomes according to their study subjects. However, the stents used in the previous studies are less useful in current practice of cardiology and there is lack of data of 3rd generation DES, which have different stent profiles and outcomes with their predecessors.
Thus we would perform a prospective randomized study in order to compare the efficacy of IVUS-guided angioplasty with conventional angioplasty-guided procedure in the long coronary lesion. Our main hypothesis is IVUS-guided 3rd generation DES implantation in the long coronary lesions would have better clinical outcomes compared with conventional angiography-guided strategy. We also intend to assess the clinical outcomes after Promus ElementTM and Resolute Integrity® implantation.
- Conditions
- Coronary Artery Disease
- Being tested
- IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertion, Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertion, Angiography guided percutaneous coronary angioplasty with Promus element stent implantation
- Keywords
- Intravenous ultrasound,, third generation drug-eluting stent
- 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.
IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertionProcedure or surgery
Resolute integrity stent implantation (diameter from 2.5mm to 3.5mm, length 30, 34, 38mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.
Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertionDevice
Resolute integrity stent implantation (diameter from 2.5mm to 3.5mm, length 30, 34, 38mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.
Angiography guided percutaneous coronary angioplasty with Promus element stent implantationDevice
Promus element stent implantation (diameter from 2.5mm to 3.5mm, length 28, 32, 36mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.
Angiography guided percutaneous coronary angioplasty with Promus element stent implantationProcedure or surgery
Promus element stent implantation (diameter from 2.5mm to 3.5mm, length 28, 32, 36mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.
| Study group | Role | What they receive |
|---|---|---|
| Resolute Integrity - IVUS | Experimental | Resolute Integrity - IVUS arm Receives: Procedure: IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertion |
| Resolute Integrity - Angio | Active comparator | Resolute Integrity - Angio arm Receives: Device: Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertion |
| Promus - Angio | Active comparator | Promus - Angio arm Receives: Device: Angiography guided percutaneous coronary angioplasty with Promus element stent implantation |
| Promus - IVUS | Active comparator | Promus - IVUS arm Receives: Procedure: Angiography guided percutaneous coronary angioplasty with Promus element stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of angiography or IVUS guided third generation stent implantation
MACEs including cardiovascular death, myocardial infarction, stent thrombosis, and target vessel revascularization
Measured: 1 year after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startOct 2013
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979744
- Sponsor's protocol ID
- 1-2013-0052
- Status last verified
- Dec 2017
- First submitted
- 24 Oct 2013
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular ULTrasound Guided Versus Conventional Angiography Guided Strategy to Deploy Zotarolimus and Everolimus Eluting Third Generation Stents in the Long Coronary Artery Lesions: ULTRA-ZET Trial
- ClinicalTrials.gov ID
- NCT01979744
- Acronym / sponsor ID
- 1-2013-0052
- Conditions
- Coronary Artery Disease
- Keywords
- Intravenous ultrasound,, third generation drug-eluting stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 8 Nov 2013 (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.
Although first generation DES reduced instent restenosis, still remained the unsolved problems such as stent thrombosis and restenosis in the era of DES. Second generation DES had been developed to improve the biocompatibility of stent coating focused on polymer compared to first generation DES, so that second generation stents showed better outcomes compared with first generation DES. On the other hands, in third generation DES, further refinement of DES involved more flexible stent platform. Promus ElementTM (Everolimus eluting stent, Boston Scientific, Nastick, MA) and Resolute Integrity® (Zotarolimus eluting stent, Medtronic Vascular, Santa Rosa, CA) are the third generation drug eluting stents which are designed to increase flexibility. In previous randomized controlled studies, both of these stents have shown at least non-inferior angiographic and clinical outcomes compared to second generation DES. However, there is lack of data about comparison of angiographic and clinical outcomes between Promus ElementTM and Resolute Integrity®.
IVUS is one of the widely used intracoronary imaging devices to provide more reproducible and accurate information about coronary anatomy than angiography in current practice.8 Optimal stent expansion assessed by intravascular ultrasound (IVUS) has been reported as an important factor to prevent stent thrombosis or restenosis.9 Accordingly, there have been many studies to evaluate the procedural or clinical benefit of IVUS guided angioplasty. However, The clinical benefit of IVUS-guided angioplasty with stent implantation is still in a controversy. In the previous studies, IVUS-guided stent implantation showed positive or negative beneficial effect on clinical outcomes according to their study subjects. However, the stents used in the previous studies are less useful in current practice of cardiology and there is lack of data of 3rd generation DES, which have different stent profiles and outcomes with their predecessors.
Thus we would perform a prospective randomized study in order to compare the efficacy of IVUS-guided angioplasty with conventional angioplasty-guided procedure in the long coronary lesion. Our main hypothesis is IVUS-guided 3rd generation DES implantation in the long coronary lesions would have better clinical outcomes compared with conventional angiography-guided strategy. We also intend to assess the clinical outcomes after Promus ElementTM and Resolute Integrity® implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Resolute Integrity - IVUS | Experimental | Procedure: IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertionResolute Integrity - IVUS arm |
| Resolute Integrity - Angio | Active comparator | Device: Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertionResolute Integrity - Angio arm |
| Promus - Angio | Active comparator | Device: Angiography guided percutaneous coronary angioplasty with Promus element stent implantationPromus - Angio arm |
| Promus - IVUS | Active comparator | Procedure: Angiography guided percutaneous coronary angioplasty with Promus element stent implantationPromus - IVUS arm |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 19 years old
- Coronary artery disease and lesions which are candidate for treatment with drug eluting stent according to current clinical practice guidelines
- PCI for lesion(s) which needs a stent of 26mm or more
- Reference diameter from 2.25 to 4.0mm
Key exclusion criteria (8 listed)
- Restenosis lesion
- Reference vessel diameter < 2.25 mm or > 4.0mm
- Primary PCI for STEMI
- Contraindication to anti-platelet agents
- Treated with any DES within 3 months at other vessel
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 |
|---|---|---|
| IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertionResolute integrity stent implantation (diameter from 2.5mm to 3.5mm, length 30, 34, 38mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results. | Procedure or surgery | Resolute Integrity - IVUS |
| Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertionResolute integrity stent implantation (diameter from 2.5mm to 3.5mm, length 30, 34, 38mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm. | Device | Resolute Integrity - Angio |
| Angiography guided percutaneous coronary angioplasty with Promus element stent implantationPromus element stent implantation (diameter from 2.5mm to 3.5mm, length 28, 32, 36mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm. | Device | Promus - Angio |
| Angiography guided percutaneous coronary angioplasty with Promus element stent implantationPromus element stent implantation (diameter from 2.5mm to 3.5mm, length 28, 32, 36mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results. | Procedure or surgery | Promus - IVUS |
Primary outcome
Efficacy of angiography or IVUS guided third generation stent implantation
Time frame: 1 year after implantation
MACEs including cardiovascular death, myocardial infarction, stent thrombosis, and target vessel revascularization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertion, Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertion and Angiography guided percutaneous coronary angioplasty with Promus element stent implantation 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 28 Mar 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of angiography or IVUS guided third generation stent implantation (time frame: 1 year after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2019.