NCT05800002Recruiting
IVUS-guided DES Implantation in Coronary Calcification
Intravascular Ultrasound Versus Angiography Guided Drug-eluting Stent Implantation for Patients With Coronary Severe Calcification: a Prospective, Multicenter, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Coronary calcified lesion is associated with a poor clinical outcome. Intravascular ultrasound (IVUS) provides anatomic information in detail about reference vessel dimensions and lesion characteristics including severity of diameter stenosis, lesion length, and morphology. Both randomized and observational studies have reported the clinical benefits of IVUS guidance for patients with chronic total occlusion (CTO), long lesions, acute coronary syndrome (ACS) with complex bifurcation lesions. Our previous ULTIMATE trial has demonstrated that IVUS-guided drug-eluting stent (DES) implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance. However, the benefit of IVUS guidance in coronary severe calcification still remains unknown in the modern DES era.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 864 (estimated)
- First submitted
- 23 Mar 2023
- Start date
- 7 Apr 2023
- Primary completion date
- 30 Mar 2026
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT05800002
What you commit to
- Study type: Interventional
- Planned participants: 864
- From 7 Apr 2023 to the primary completion date, 30 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intolerant of antithrombotic therapy;
- Scheduled major surgery in the next 12 months;
- Previous drug-eluting stent implantation in target vessel;
Other illness
- History of major hemorrhage (intracranial, gastrointestinal, and so on);
Lab values
- Left ventricular ejection fraction \< 25%;
Age
- Age less than 18-year-old;
Other
- Comorbidity with a life expectancy \<12 months;
- Significant anemia, thrombocytopenia, or leucopenia;
- Chronic total occlusion lesion not recanalized;
- Uremia dependent on dialysis treatment;
Who the study is looking for
- Silent ischemia, stable or unstable angina, non-ST-segment elevation myocardial infarction \> 48 hours, or ST-segment elevation myocardial infarction \> 7 days;
- De novo coronary lesion eligible for drug-eluting stent implantation;
- Target lesion with severe calcification;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.