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
1 other identifier
interventional
568
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Oct 2013
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 24, 2013
CompletedFirst Posted
Study publicly available on registry
November 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedMarch 28, 2019
December 1, 2017
4.1 years
October 24, 2013
March 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of angiography or IVUS guided third generation stent implantation
MACEs including cardiovascular death, myocardial infarction, stent thrombosis, and target vessel revascularization
1 year after implantation
Study Arms (4)
Resolute Integrity - IVUS
EXPERIMENTALResolute Integrity - IVUS arm
Resolute Integrity - Angio
ACTIVE COMPARATORResolute Integrity - Angio arm
Promus - Angio
ACTIVE COMPARATORPromus - Angio arm
Promus - IVUS
ACTIVE COMPARATORPromus - IVUS arm
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2013
First Posted
November 8, 2013
Study Start
October 1, 2013
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
March 28, 2019
Record last verified: 2017-12