Status:
COMPLETED
Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions （ULTIMATE Trial）
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ei...
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. Primar...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures;
- Men and women 18 years and older;.
- Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;
- Native coronary lesion suitable for drug-eluting stent placement and IVUS imaging.
Exclusion
- Pregnancy and breast feeding mother;
- Co-morbidity with an estimated life expectancy of \< 50 % at 12 months;
- Scheduled major surgery in the next 12 months;
- Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
- Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days;
- Known allergy against ticagrelor, or against clopidogrel, or aspirin History of major hemorrhage (intracranial, gastrointestinal, etc.);
- Chronic total occlusion lesion in either LAD, or LCX or RCA not re-canalized;
- Severe calcification needing rotational atherectomy；
- Patient with STEMI (within 24-hour from the onset of chest pain to admission).
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
1448 Patients enrolled
Trial Details
Trial ID
NCT02215915
Start Date
August 1 2014
End Date
October 30 2020
Last Update
November 3 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006