Trials / Completed
CompletedNCT02215915
Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions （ULTIMATE Trial）
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,448 (actual)
- Sponsor
- Nanjing First Hospital, Nanjing Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The study is prospectively conducted at 8 high-volume PCI centers in China with IVUS expertise. Clinic follow-up are planned in all patients 12 months after implantation of drug eluting stents. Primary endpoint is target vessel failure. The study is powered for primary endpoint, which are likely to reach significance at the level P \< 0.05 even at a follow-up drop-out rate up to 10%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2017-05-30
- Completion
- 2020-10-30
- First posted
- 2014-08-13
- Last updated
- 2020-11-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02215915. Inclusion in this directory is not an endorsement.