Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions (ULTIMATE Trial)
NCT02215915 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1448
Last updated 2020-11-03
Summary
A number of 1448 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and IVUS imaging are openly randomized 1:1 to either IVUS guidance or angiographic guidance groups.
Conditions
Interventions
- PROCEDURE
-
Angiography
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.
- PROCEDURE
-
IVUS
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
-
DES implantation
Sponsors & Collaborators
-
Nanjing First Hospital, Nanjing Medical University
lead OTHER
Principal Investigators
-
Shaoliang Chen, MD · Nanjing First Hospital, Nanjing Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-01
- Primary Completion
- 2017-05-30
- Completion
- 2020-10-30
Countries
- China
Study Locations
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