NCT03381872Active, not recruiting
Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease
Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention (RENOVATE-COMPLEX-PCI)
Source: ClinicalTrials.gov · Last updated 22 Aug 2025
Brief summary (registry, in English)
The aim of the study is to compare clinical outcomes between intravascular imaging-guided versus angiography-guided percutaneous coronary intervention (PCI) in complex lesions.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1639 (actual)
- First submitted
- 16 Dec 2017
- Start date
- 10 May 2018
- Primary completion date
- 10 May 2022
- Lead sponsor
- Samsung Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT03381872
What you commit to
- Study type: Interventional
- Participants enrolled: 1639
- From 10 May 2018 to the primary completion date, 10 May 2022
- 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.
Other illness
- Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
Other
- Target lesions not amenable for PCI by operators' decision
- Cardiogenic shock (Killip class IV) at presentation
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
- Pregnancy or breast feeding
- Unwillingness or inability to comply with the procedures described in this protocol.
Who the study is looking for
- Subject age ≥19 years old
- Coronary artery disease requiring PCI
- Patients with complex lesion
- True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
- Chronic total occlusion (≥3 months) as target lesion
- Unprotected LM disease PCI (LM ostium, body, distal LM bifurcation including non-true bifurcation)
- Long coronary lesions (implanted stent ≥38 mm in length)
- Multi-vessel PCI (≥2 vessels treated at one PCI session)
- Multiple stents needed (≥3 more stent per patient)
- In-stent restenosis lesion as target lesion
- Severely calcified lesion (encircling calcium in angiography)
- Ostial coronary lesion (LAD, LCX, RCA)
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Age in the registry: 19 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 |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
Related publications
- Intravascular Imaging- vs Angiography-Guided Complex PCI: 5-Year Outcomes From a Randomized Trial.J Am Coll Cardiol · 2026 · PMID 41778943
This page is information, not medical advice. Discuss any trial with your doctor.